AUTHENTICATED
US. GOVERNMENT
INFORMATION ^
PROTECTIONS FOR FOSTER CHILDREN
ENROLLED IN CLINICAL TRIALS
HEARING
BEFORE THE
SUBCOMMITTEE ON HUIilAN RESOURCES
OF THE
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATDH]S
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
MAY 18, 2005
Serial No. 109-8
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
E. CLAY SHAW, JR., Florida
NANCY L. JOHNSON, Connecticut
WALLY HERGER, California
JIM MCCRERY, Louisiana
DAVE CAMP, Michigan
JIM RAMSTAD, Minnesota
JIM NUSSLE, Iowa
SAM JOHNSON, Texas
PHIL ENGLISH, Pennsylvania
J.D. HAYWORTH, Arizona
JERRY WELLER, Illinois
KENNY C. HULSHOF, Missouri
RON LEWIS, Kentucky
MARK FOLEY, Florida
KEVIN BRADY, Texas
THOMAS M. REYNOLDS, New York
PAUL RYAN, Wisconsin
ERIC CANTOR, Virginia
JOHN LINDER, Georgia
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
CHARLES B. RANGEL, New York
FORTNEY PETE STARK, California
SANDER M. LEVIN, Michigan
BENJAMIN L. CARDIN, Maryland
JIM MCDERMOTT, Washington
JOHN LEWIS, Georgia
RICHARD E. NEAL, Massachusetts
MICHAEL R. MCNULTY, New York
WILLIAM J. JEFFERSON, Louisiana
JOHN S. TANNER, Tennessee
XAVIER BECERRA, California
LLOYD DOGGETT, Texas
EARL POMEROY, North Dakota
STEPHANIE TUBBS JONES, Ohio
MIKE THOMPSON, California
JOHN B. LARSON, Connecticut
RAHM EMANUEL, Illinois
DEVIN NUNES, California
Allison H. Giles, Chief of Staff
Janice Mays, Minority Chief Counsel
SUBCOMMITTEE ON HUMAN RESOURCES
WALLY HERGER, California, Chairman
NANCY L. JOHNSON, Connecticut
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
JIM MCCRERY, Louisiana
DAVE CAMP, Michigan
PHIL ENGLISH, Pennsylvania
JIM MCDERMOTT, Washington
BENJAMIN L. CARDIN, Maryland
FORTNEY PETE STARK, California
XAVIER BECERRA, California
RAHM EMANUEL, Illinois
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public hearing records
of the Committee on Ways and Means are also published in electronic form. The printed
hearing record remains the official version. Because electronic submissions are used to
prepare both printed and electronic versions of the hearing record, the process of converting
between various electronic formats may introduce unintentional errors or omissions. Such occur-
rences are inherent in the current publication process and should diminish as the process
is further refined.
CONTENTS
Page
Advisory of May 11, 2005, announcing the hearing 2
WITNESSES
U.S. Department of Health and Human Services, Hon. Donald Young, M.D.,
Principal Deputy Assistant Secretary for Planning and Evaluation 7
The New York Academy of Medicine, Alan Eleischman 27
Wisconsin Department of Health and Eamily Services, Roberta Harris 31
Association for the Accreditation of Human Research Protection Programs,
Inc., Maijorie Speers 36
American Academy of Pediatrics, Moira Szilagyi 38
SUBMISSIONS FOR THE RECORD
Ablechild.org, New Canaan, CT, Sheila Matthews and Gloria M. Wright,
statement and attachment 50
Alliance for Human Research Protection, New York, NY, Vera Hassner
Sharav and John H. Noble, Jr., Ph.D., statement 52
American Family Rights Association, Morongo Valley, CA, Cheri Carlene
Campbell, statement 55
Asplund, Linn, Waterbury, CT, statement 57
Child Welfare League of America, Alexandra Yoffie, statement 58
Jacobi Medical Center, Bronx, NY, Andrew Wiznia, letter 58
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, Alfred
Sommer, M.D., letter 60
National Institute of Allergy and Infectious Diseases, Division of Aids, Office
for Policy in Clinical Research Operations, Potomac, MD, Jonathan M.
Fishbein, M.D., letter 61
New York City Administration for Children’s Services, New York, NY, John
Mattingly, statement 63
Pediatric Aids Clinical Trials Group, University of California, San Diego,
La Jolla, CA, Stephen A. Spector, M.D., statement 67
Sabato, Patricia, Sandy Hook, CT, statement 68
Schuldt, Sharon, Rockford, IL, letter 69
William Glasser, Inc., Chatsworth, CA, William Glasser, M.D., letter 71
hi
PROTECTIONS FOR FOSTER CHILDREN
ENROLLED IN CLINICAL TRIALS
WEDNESDAY, MAY 18, 2005
U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Human Resources,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:09 p.m., in room
B-318, Rayburn House Office Building, Hon. Wally Herger (Chair-
man of the Subcommittee) presiding.
[The advisory announcing the hearing follows:]
( 1 )
2
ADVISORY
FROM THE COMMITTEE ON WAYS AND MEANS
SUBCOMMITTEE ON HUMAN RESOURCES
FOR IMMEDIATE RE T, EA SE CONTACT: (202) 225-1026
May 11, 2005
No. HR-2
Herger Announces Hearing on Protections for
Foster Children Enrolled in Clinical Trials
Congressman Wally Herger (R-CA), Chairman, Subcommittee on Human Re-
sources of the Committee on Ways and Means, today announced that the Sub-
committee will hold a hearing on protections for foster children enrolled in clinical
trials. The hearing will take plaee on Wednesday, May 18, 2005, in room B-
318 Rayhurn House Office Building, beginning at 2:00 p.m.
In view of the limited time available to hear witnesses, oral testimony at this
hearing will be from invited witnesses only. Invited witnesses will include experts
familiar with issues related to the enrollment of foster children in clinical trials.
However, any individual or organization not scheduled for an oral appearance may
submit a written statement for consideration by the Subcommittee for inclusion in
the printed record of the hearing.
BACKGROUND :
Recent media reports raised concerns regarding protections in place prior to the
enrollment of foster children in clinical drug trials. These included allegations that
in some cases foster children may have been enrolled in studies without the benefit
of certain protections, such as the appointment of an independent advocate for the
child. At the same time, individuals familiar with these studies contend that the en-
rollment of foster children enhanced their health by offering the best medical treat-
ment available and that independent advocates were not necessary in all cases.
For children who may not safely remain with their families, foster care is a tem-
porary setting in which foster parents, social workers, and court personnel work to
protect the child’s best interests in lieu of their biological parents. Federal policy has
been enacted, most recently with the Adoption and Safe Families Act of 1997 (P.L.
105-89), to ensure that the safety of foster children is paramount in any decision
made on the child’s behalf. This hearing will examine (1) policy issues surrounding
the enrollment of foster children in clinical trials, and (2) whether adequate protec-
tions are in place to ensure the safety and well-being of foster children in such
trials.
In announcing the hearing. Chairman Wally Herger said: “This hearing will ex-
plore issues surrounding the placement of foster children in clinical drug trials, in-
cluding under what conditions participation is permitted. We are concerned about
recent allegations involving the enrollment of foster children in such trials. This
hearing will help us assess whether there is any substance to these allegations and
if so, what response is appropriate.”
FOCUS OF THE HEARING :
The focus of the hearing is on protections for foster children enrolled in clinical
trials.
DETATT,S FOR SUBMISSION OF WRITTEN COMMENTS:
Please Note: Any person(s) and/or organization(s) wishing to submit for the hear-
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3
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FORMATTING REQUIREMENTS:
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mittee as noted above.
Chairman MERGER. Good afternoon, and welcome to today’s
hearing. To begin the hearing today, I would like to make note that
we have a new Member on the Subcommittee, Mr. Devin Nunes of
California. Welcome, Devin. We look forward to working with you
on the many important issues within the Subcommittee’s jurisdic-
tion.
At today’s hearing, the Subcommittee will examine an extraor-
dinarily sensitive topic, the enrollment of children in foster care in
clinical drug trials involving experimental but potentially lifesaving
drugs. Children in foster care have been separated from their bio-
logical parents and placed in a temporary setting which can last for
years or, in some cases, their entire childhood. Many of these chil-
dren have special medical needs, including life-threatening ill-
nesses like Acquired Immunodeficiency Syndrome (AIDS). Thou-
sands of foster children in the late 1980s and early 1990s were af-
4
flicted by AIDS. Treatments for children had not yet been found or
tested. For some of these children, clinical trials were seen as a
promising and possibly only way to save, lengthen or improve these
young lives. When biological parents could not be found or were in-
capacitated due to addiction or illness, social workers, court per-
sonnel and others involved in the children’s care had to make life-
and-death decisions about whether foster children should be placed
in clinical trials. Those trials involved both hope and risk. Concerns
have been raised about the right balance between hope and risk,
and who gets to make that critical decision.
Recent news stories report that States have a variety of policies
for when children in foster care may or may not participate in clin-
ical trials. Even though there are Federal guidelines, there is no
consistent policy across States. These reports also suggest that, in
some cases, protections were either not enforced or were inad-
equate. These are serious allegations. That is why it is important
that we closely examine the facts. It seems to me there are three
main questions involved in today’s hearings. First, should children
in foster care be involved in clinical trials? Second, if foster chil-
dren are permitted to participate in clinical trials, what are the
protections now in place to ensure their safety? Third, are those
protections adequate? Some States have adopted the policy that
children in foster care simply cannot participate in clinical trials,
as we will hear described shortly. Other States permit participa-
tion, but only based on the decision of a judge or following the
naming of an independent advocate to monitor the foster child’s
best interest. Still other States rely on the foster care system and
its caseworkers, medical experts and foster parents to make these
decisions. In some cases, these decisions are made after trying to
consult the child’s biological parents.
As I mentioned earlier, our purpose today is to understand these
various measures, all of which are designed to protect children in
foster care to determine whether those protections are adequate
and appropriate. In other words, how do we balance risk and hope?
Given the lack of available information on this topic, I have asked
the U.S. Department of Health and Human Services (HHS) to sur-
vey the 50 States about the specific policies and protections they
have in place regarding the enrollment of foster children in clinical
trials. I look forward to the results of that survey.
We welcome all our witnesses today to explore these issues. I
note there are no Democrat or Republican witnesses here today. I
appreciate the cooperation of Mr. McDermott and his staff in se-
lecting the witnesses appearing before us. Joining us are experts
on topics ranging from Federal protections for children enrolled in
clinical studies to individuals familiar with State policies regarding
foster child enrollment. I would also note that we have written
background information and written testimony from a variety of
sources who could not join us today, including the child protection
agencies of New York City and the State of Illinois. The official
record of this hearing will remain open for 2 weeks should others
wish to offer their input for this Subcommittee’s consideration.
We look forward to today’s testimony and our witnesses’ help in
answering our many questions and helping us decide how best to
proceed. Without objection, each Member will have the opportunity
5
to submit a written statement and have it included in the record
at this point. Mr. McDermott, would you care to make a statement?
[The prepared statement of Chairman Merger follows:]
Opening Statement of The Honorable Wally Herger, Chairman, and a
Representative in Congress from the State of California
Today the Subcommittee will examine an extraordinarily sensitive topic — the en-
rollment of children in foster care in clinical drug trials involving experimental, but
potentially life-saving drugs.
Children in foster care have been separated from their biological parents and
placed in a temporary setting which can last for years or, in some cases, their entire
childhood. Many of these children have special medical needs, including life-threat-
ening illnesses like AIDS.
AIDS afflicted thousands of foster children in the late 1980s and early 1990s
Treatments for children had not yet been found or tested. For some of these chil-
dren, clinical trials were seen as a promising, and possibly only, way to save, length-
en or improve these young lives.
When biological parents could not be found or were incapacitated due to addiction
or illness, social workers, court personnel and others involved in the children’s care
had to make life and death decisions about whether foster children should be placed
in clinical trials.
Those trials involved both hope and risk. Concerns have been raised about the
right balance between hope and risk, and who gets to make that critical decision.
Recent news stories report that states have a variety of policies for when children
in foster care may or may not participate in clinical trials. Even though there are
federal guidelines, there is no consistent policy across States.
These reports also suggest that in some cases, protections were either not en-
forced or were inadequate. These are serious allegations. That is why it is important
that we closely examine the facts.
It seems to me there are three main questions involved in today’s hearing:
• First, should children in foster care be involved in clinical trials?
• Second, if foster children are permitted to participate in clinical trials, what are
the protections now in place to ensure their safety?
• And third, are those protections adequate?
Some states have adopted the policy that children in foster care simply cannot
participate in clinical trials, as we will hear described shortly.
Others states permit participation, but only based on the decision of a judge, or
following the naming of an independent advocate to monitor the foster child’s best
interests.
Still other states rely on the foster care system and its caseworkers, medical ex-
perts, and foster parents to make decisions about whether foster children may be
included in clinical trials, in some cases after trying to consult the child’s biological
parents.
As I mentioned earlier, our purpose today is to understand these various meas-
ures, all of which are designed to protect children in foster care, to determine
whether those protections are adequate and appropriate.
In other words, how do we balance risk and hope.
Given the lack of available information on this topic, I have asked the Department
of Health and Human Services to survey states about the specific policies and pro-
tections they have in place regarding the enrollment of foster children in clinical
trials. I look forward to the results of that survey.
We welcome all our witnesses today to explore these issues. Joining us are experts
on topics ranging from federal protections for children enrolled in clinical studies
to state policies regarding foster child enrollment.
I would also note that we have received background information and written testi-
mony from a variety of sources who could not join us today, including the child pro-
tection agencies of New York City and the State of Illinois.
And the official record of this hearing will remain open for two weeks should oth-
ers wish to offer their input for the Subcommittee’s consideration.
We look forward to today’s testimony, and our witnesses’ help in answering our
many questions and helping us decide how best to proceed.
6
Mr. MCDERMOTT. Surely. Thank you, Mr. Chairman. First of
all, I want to thank the Chairman for having this hearing. I think
it is an important issue and one that requires us to be thoughtful.
Sometimes issues like this can be sort of explosive, but I think this
is an issue to be thoughtful about because I am sure many were
shocked when they read the recent press accounts of foster kids
being involved in clinical trials without adequate protection. As a
physician, I know the role medicine plays in saving and improving
lives every day. I have been involved in the AIDS epidemic begin-
ning when I was with the State Department in 1987, so I have
seen the evolution of the Department. Many of these cases we are
talking about here were late eighties cases, early nineties cases. I
think we have to put things in perspective of the real crash feeling
there was in those days about getting some treatment and figuring
out what we could do for a variety of people in this situation.
However, we learned through top-notch investigative reporting
by the AP that children in the child welfare system had partici-
pated in scientific experiments used to determine the effectiveness
of AIDS medication, and that participating, in my view, is not nec-
essarily bad. I want to say that right up front, because trials are
scientific paths to new and more effective treatments. I think what
is true, however, is we must be assured that the system defends
the best interests of the children involved in these studies. They
are alone. They have been taken away from their parents. They are
without an advocate. They are vulnerable, and they could be taken
advantage of by the system if it fails them.
Over the last 18 months, this Subcommittee has heard hearings
about a number of issues affecting kids in the Federal, State child
welfare programs, and this issue is like many of them: It is has the
potential for being explosive. The child welfare program in the rich-
est, most powerful country in the world is and has been often an
abysmal failure. Now, we don’t need proof of more of that. We can
give you all kinds of examples of it. We know about kids losing
their lives in the child welfare system. Practically every State legis-
lature every year deals with one case or another, and everybody
wrings their hands, and the problems go on. The kids are some-
times locked up. Sometimes starved under the supervision of the
agencies. We know the children have been used without proper su-
pervision for drug testing.
Now, the question the public has to ask us and I think we have
to ask ourselves on this Subcommittee is, how do we give that
proper supervision? When are we going to reform the child welfare
system so that we protect these vulnerable kids and provide them
with the opportunity to succeed? They have enough strikes against
them going in because they are in the foster system, and the ques-
tion really is, what can we do not to make it worse for them but
to make it better?
We have a group of distinguished witnesses here today, and I for
one expect them to give us ideas about how we can improve the
system for children. The Subcommittee put out a press release an-
nouncing today’s hearing. Now, press releases are one part of the
political process, but our challenge and really what the public
should demand of us is a bipartisan Subcommittee action. I really
think, Mr. Chairman, we need to act to improve the welfare of chil-
7
dren that do not have a stable and safe family. We really need re-
form on a variety of things, but it takes courage and leadership and
new resources, but it needs to be done. It is not an easy job. I dealt
with these issues when I was in the State legislature, and they are
no less contentious now up here than they were down there. Our
Nation’s children need us. They need what we put together in a
child welfare program that lifts them up rather than puts them
down or lets them down. I for one am grateful for you for having
this hearing, and I hope that we can come out of it with some
things that we can then put into law and actually do something.
We have talked a lot and listened a lot, but it is time for us to do
something. Thank you, Mr. Chairman.
Chairman MERGER. Thank you, Mr. McDermott. Before we
move on to our testimony, I want to remind our witnesses to limit
their oral statement to 5 minutes. However, without objection, all
the written testimony will be made a part of the permanent record.
To start our hearing this afternoon, we will hear from the Honor-
able Donald Young, M.D., who is the acting principal deputy assist-
ant secretary for planning and evaluation at HHS. Dr. Young,
please proceed with your testimony.
STATEMENT OF DONALD YOUNG, M.D., ACTING PRINCIPAL
DEPUTY ASSISTANT SECRETARY FOR PLANNING AND EVAL-
UATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERV-
ICES
Dr. YOUNG. Mr. Chairman, distinguished Members of the Sub-
committee, thank you for inviting me here today to discuss Federal
protections for foster children enrolled in clinical trials. I am Dr.
Donald Young, deputy assistant secretary for planning and evalua-
tion in HHS. The President and Secretary Leavitt have as a first
principle the protection of the most vulnerable in our population.
Foster children are certainly vulnerable, and failing to protect
them will not be tolerated.
Dramatic advances in prevention and treatment of disease have
been achieved through research. A crucial part of these medical ad-
vances involves participation of human subjects, including children,
in clinical trials. The Department of Health and Human Services
is deeply committed to ensuring the protection of the rights and
welfare of every individual who participates in clinical research.
This afternoon, I will discuss the evolution of the Human Immuno-
deficiency Virus (HIVyAIDS, the management of the disease, pedi-
atric AIDS and foster care, and the Federal protections in place to
ensure the safety of human subjects, including children, and chil-
dren who are wards.
In 1990, as many as 2,000 babies were born infected with HIV.
Now that number has been reduced to a bit more than 200 a year
in the United States.. HIV has evolved from a disease that kills to
a disease that is chronic and manageable. Clinical research includ-
ing research in children is necessary to make advances in medicine.
Clinical research involves risks, however, and it is the responsi-
bility of the medical research community to ensure that all trial
participants fully understand both the potential benefits and the
potential risks of their participation.
8
It is estimated that, through 1989, between 16 and 22 percent of
pediatric AIDS patients were children in foster care. Many of these
children were placed in foster care because the caretaker parent
had died or become incapacitated by AIDS, or because of neglect,
abuse, or abandonment associated with parental drug abuse. The
fact that fewer than 2 percent of foster children diagnosed as HIV-
positive in 1989 were participating in clinical trials was viewed as
evidence that the foster care system had failed to completely and
effectively cope with the influx of HIV-infected children.
At the time, most State laws allowed only for standard medical
treatment for children in foster care; because there were no stand-
ard treatments for HIV-infected children, this limitation rep-
resented a critical barrier to medical care for children with HIV.
Federal regulations are in place to provide protections for human
subjects, including children and foster children, involved in HHS
conducted, supported or regulated research. Ultimately, however, it
is the State and in some cases county foster care agencies that de-
cide who provides permission for these children to be enrolled in
clinical trials. Institutional review boards (IRB) — working with re-
searchers establish within Federal guidelines what procedures
should be followed to acquire consent in specific study protocols.
The HHS and Food and Drug Administration (FDA) regulations
also contain a number of other requirements relating to IRB mem-
bership and procedures, criteria for IRB approval of research, sus-
pension or termination of IRB approval research and general re-
quirements for informed consent.
The regulations permit IRBs to approve three categories of re-
search or clinical investigation involving children as research sub-
jects. A fourth category requires an additional level of review. First,
research or clinical investigations not involving greater than mini-
mal risk to the children: There, the IRB must determine that the
research or clinical investigation presents no greater than minimal
risk to the children. Second, research or clinical investigation in-
volving greater than minimal risk but preserving the prospect of
direct benefit to the individual child subjects: Here, the IRB must
determine the risk is justified by the anticipated benefits to the
subjects, the relation of the anticipated benefit to the risk pre-
sented by the study is at least as favorable to the subjects as that
provided by alternative available approaches.
In each of the next two categories, HHS and FDA regulations in-
clude a provision that provides additional protections for children
who are wards of the State or any other agency, institution, or enti-
ty. First, research or clinical investigations involving greater than
minimal risk and no prospect for direct benefit to the individual
child subjects but likely to yield generalizeable knowledge about
the subject’s disorder or condition: The IRB must determine the
risk of the research or clinical investigation represents a minor in-
crease over minimal risk; the intervention or procedure presents
experiences to the child subjects that are reasonably commensurate
with those inherent in their actual or expected medical, dental,
psychological, social or educational situations; the intervention or
procedure is likely to yield generalizeable knowledge about the sub-
ject’s disorder or condition which is of vital importance for the un-
derstanding or amelioration of the disorder or condition. Second,
9
research or clinical investigation that the IRB believes does not
meet the above categories of the HHS or FDA regulations but finds
that the research presents a reasonable opportunity to further the
understanding, prevention or alleviation of a serious problem af-
fecting the health or welfare of children requires a specific level of
HHS review beyond that provided by the IRB.
In all cases, the IRB must ensure that adequate provisions have
been made for soliciting permission of parents or legal guardians
and the assent of the children to the extent required by HHS and
FDA regulations. Before children who are wards of the State or any
other agency, institution or entity can be included in either of the
last two categories of research or clinical investigations, the re-
search must meet the following conditions: The research must ei-
ther be related to the children’s status as wards or conducted in
schools, camps, hospitals, institutions or similar settings in which
the majority of children involved as subjects are not wards. The
IRB must require appointment of an advocate for each child who
is a ward in addition to any other individual acting on behalf of the
child as guardian.
The Office of Human Research Protections (OHRP) and FDA
have implemented oversight activities both to respond to com-
plaints and to monitor compliance with Federal regulations.
OHRP’s compliance oversight activities can be divided into three
major categories. First, for-cause oversight investigations; second,
not-for-cause compliance oversight surveillance evaluations; and,
third, review and analysis of institutional reports of noncompliance,
unanticipated problems involving risks to subjects, or suspensions
or terminations of IRB approval of research.
FDA regulation and oversight for clinical research extend not
only to IRBs and institutions but to clinical investigators, research
sponsors, contract research organizations, laboratory facilities con-
ducting preclinical research and bioequivalence firms. As you know,
Mr. Chairman, of recent press reports there is an ongoing inves-
tigation, and I will not be able to answer any questions related to
the investigation.
In conclusion, we continue to address challenges posed by the
threat of HIV/AIDS and are committed to basic and clinical re-
search to strengthen the Nation’s ability to cope with this infec-
tious disease. The protection of human subjects, including children,
in clinical trials has been and will remain a top priority for HHS.
HHS is firmly committed to the protection of the rights and welfare
of every individual who participates in human research, consistent
with sound ethical standards and regulatory requirements. I will
be happy to answer any questions.
[The prepared statement of Dr. Young follows:]
Statement of The Honorable Donald Young, M.D., Prineipal Deputy Assist-
ant Seeretary for Planning and Evaluation, U.S. Department of Health
and Human Serviees
Mr. Chairman and Distinguished Members of the Subcommittee, thank you for in-
viting me here today to discuss federal protections of foster children enrolled in clin-
ical trials. I am Dr. Donald Young, the Deputy Assistant Secretary for Planning in
Evaluation in the U.S. Department of Health and Human Services. The President
and Secretary Leavitt have as a first principle the protection of the most vulnerable
in our population. Foster children are certainly vulnerable and failing to protect
them will not be tolerated. Dramatic advances in prevention and treatment of dis-
10
ease have been achieved through research. A crucial part of this research involves
the participation of human subjects, including children, in clinical trials. Clinical
trials of drugs are necessary in children to determine their safety and efficacy in
this age group of patients; studies in adults may not adequately predict drug prop-
erties in children. Federal policy has sought to preserve the benefits of this re-
search, while at the same time protecting against possible abuse or harm to re-
search subjects. The Department of Health and Human Services is deeply com-
mitted to ensure the protection of the rights and welfare of every individual who
participates in clinical research.
To provide a better understanding of the issue, I will discuss with you the evo-
lution of HIV/AIDS and the management of the disease, pediatric AIDS and foster
care, and the federal protections in place to ensure the safety of human subjects,
including children and children who are wards, in research.
Evolution in the Management of HIV/AIDS
Since the world first became aware of AIDS in 1981, the disease has spread
around the globe. Today, approximately 39.4 million people worldwide are living
with HIV/AIDS. Approximately 2.2 million children are now living with HIV/AIDS.
During the past year, approximately 640,000 new HIV infections and 510,000
deaths occurred in children.
Despite these sobering statistics, dramatic advances have been made in the man-
agement of HIV infection since HIV was first discovered over two decades ago. In
1990, as many as 2000 babies were born infected with HIV; now that number has
been reduced to a bit more than 200 a year in the U.S. From 1985 to 1999, AIDS
cases in U.S. children decreased 81%. From 1998 to 2002, the estimated number of
children dying from AIDS decreased 68%.
Much has been accomplished since the early days of the HIV/AIDS epidemic, in-
cluding significant advances in treatment and prevention. HIV has evolved from a
disease that kills to a disease that is chronic and manageable. Research has been
pivotal to understanding HIV/AIDS and managing the disease. In the United States
and other western countries, potent combinations of anti-HIV drugs have dramati-
cally reduced the numbers of new AIDS cases and deaths due to HIV/AIDS. Today,
there are over 20 antiretroviral medications that are approved by the Food and
Drug Administration (FDA). As another example of the success of research, a pivotal
National Institutes of Health (NIH)-supported study conducted in Uganda dem-
onstrated that a single dose of the drug nevirapine given to an HIV-infected woman
at the onset of labor, combined with a single dose for the infant just after birth,
was 50 percent more effective in preventing transmission to the baby than was a
short course of the drug AZT. Research is now underway to determine if the use
of nevirapine or other drugs can prevent transmission through breastfeeding, a
major mode of mother-to-infant transmission. Other HIV prevention strategies in-
clude development of effective chemical and physical barrier methods, research on
the use of these methods among different populations, and a study of how
antiretroviral therapy might prevent transmission by reducing how much virus a
patient sheds in their genital track or in breast milk. However, the early clinical
trials of these therapies were conducted only in adults. Pediatric formulations of
these treatments were not approved for young children with HIV/AIDS because suf-
ficient studies had not been conducted in children.
Importance of Clinical Research
Clinical research, including research in children is necessary to make advances
in medicine. Clinical research involves risks, however, and it is the responsibility
of the medical research community to ensure that all trial participants fully under-
stand both the potential benefits and the potential risks of their participation.
As I will describe in more detail below, federal regulations provide specific protec-
tions for children and additional protections for wards of the state participating in
some forms of clinical trials. Ultimately, however, it is the state, and in some cases
county foster care agencies that decide how informed consent is provided for these
children. Institutional Review Boards (IRBs) working with researchers, establish,
within federal guidelines, what procedures should be followed to acquire consent in
specific study protocols.
HHS continues to believe strongly that clinical trials to test new treatments in
children are essential and that the framework established by the existing regulation
offers adequate protection for individuals participating in trials. We also recognize,
however, the importance of continued vigilance to ensure the regulations are ad-
hered to by investigators and the IRBs that oversee their activities.
11
Pediatric AIDS and Foster Care — ^An Historical Perspective
Nearly three-quarters of the 3,000 pediatric AIDS cases recorded by the Centers
for Disease Control and Prevention by 1991 were in children with at least one par-
ent who was an intravenous drug user. Many of these children were placed in foster
care because the caretaker parent had died or become incapacitated by AIDS, or be-
cause of neglect, abuse or abandonment associated with parental drug abuse. This
was also the period during which “boarder babies” regularly made the headlines —
children abandoned in hospitals who were ready to leave but for whom appropriate
foster care placements were unavailable. It is estimated that through 1989, that be-
tween 16 and 22 percent of pediatric AIDS patients were children in foster care.
This significant overlap between risk factors for HIV and the need for foster care
meant that pediatric AIDS became a particular concern for child welfare agencies
in large cities, where most pediatric AIDS cases were concentrated.
As pediatric AIDS became more prevalent, little was known about the effective-
ness or proper dosages in children of drug therapies that were yielding good results
in adults. But these treatments seemed to hold the promise of longer and higher
quality life for many children who otherwise seemed doomed. State child welfare
agencies were strongly urged to reduce barriers to foster children’s participation in
such trials. The fact that fewer than 2% of foster children diagnosed as HIV positive
in 1989 were participating in clinical trials was viewed as evidence that “the foster
care system has failed to competently and effectively cope with the influx of HIV-
infected children” (McNutt, 1994).
A study published in 1990 found that only seven states had implemented formal
policies regarding the participation of foster children in clinical trials, and five
states had “mechanisms” through which it was possible to enroll such children in
trials. Although the state had legal custody of the children, the permission of bio-
logical parents was required in four of the twelve states that had either “policies”
or “mechanisms” (Martin and Sacks, 1990). The same research study found that 16
percent of 432 children enrolled in pediatric AIDS trials at the time were in foster
care (a total of 69 children), and that nearly three times that many foster children
were known to be eligible for those trials but could not be enrolled because a parent
or guardian’s permission could not be obtained.
In the Omnibus Budget Reconciliation Act of 1987, (P.L. 100-203, section 9138),
Congress required the Secretary of HHS to provide information about children with
AIDS who had been placed in foster care. The report prepared in response to this
congressional mandate found that, in 1989, the states were aware of 804 current
and 979 cumulative cases of HIV positive children in foster care nationally, most
of them concentrated in just a few states. By that year only 6 states had seen at
least 50 cumulative cases of HIV among children in foster care, and 20 states had
never cared for a foster child with HIV. At the time, most state laws allowed only
for “standard medical treatment” for children in foster care. But because there were
no standard treatments for HIV-infected children, this limitation represented a crit-
ical barrier to medical care for children with HIV. The report recommended that
“State and local child welfare agencies should create systems to manage the partici-
pation of children in foster care in special medical treatment and experimental
trials” (HHS/ASPE, 1989, p. 60).
Efforts in the early 1990s to increase the enrollment of foster children in clinical
trials affected state policies that in many cases continue to the present. Today, child
welfare agencies continue to differ in their policies regarding whether or under what
circumstances children in foster care may be enrolled in clinical trials. Information
gathered from several state foster care agencies suggests that authority to provide
permission for other than standard medical treatment typically lies either with the
judge supervising the foster care case, with a senior official within the foster care
agency, or with a guardian ad litem. Some states continue to preclude the enroll-
ment of foster children in experimental trials altogether, or will provide permission
on behalf of the child only if the biological parents also give permission for the
child’s participation. Under the federal foster care program, health care decisions on
behalf of individual foster children are left to states that are acting as parents with
respect to children in their custody and that are responsible for assuring the health
care needs of foster children are met. With respect to enrolling children in particular
clinical trials, the procedures established for each study by the IRB and researcher,
working within the federal human subjects regulations described below, would guide
children’s participation.
Protection of Human Subjects Regulations
Federal Regulations are in place to provide protections for human subjects in-
volved in HHS conducted, supported, or regulated research. Regulations exist to pro-
12
tect human subjects, including children and foster children, who participate in re-
search.
The HHS and FDA Protection of Human Subject Regulations are codified at 45
CFR part 46, and 21 CFR part 50 and 56, respectively. The regulations in subpart
A of 45 CFR part 46 include basic protections for human subjects involved in both
biomedical and behavioral research.
In 1991, 14 other Federal departments and agencies joined HHS in adopting a
uniform set of regulations that are identical to subpart A of 45 CFR part 46. This
uniform set of regulations is known as the Federal Policy for the Protection of
Human Subjects, also referred to as the Common Rule. FDA’s Protection of Human
Subjects regulations at 21 CFR parts 50 and 56 are similar to those in the Common
Rule.
The HHS protection of human subject regulations are based in large part on the
Belmont Report written in 1978 by the Congressionally created National Commis-
sion for the Protection of Human Subjects of Biomedical Behavioral Research. The
Belmont Report identifies three fundamental ethical principles for all human sub-
jects research — respect for persons, beneficence, and justice.
The HHS regulations at 45 CFR part 46 apply to all non-exempt research involv-
ing human subjects that is conducted or supported by HHS. These regulations in-
clude provisions for IRB review, informed consent, and assurances of compliance.
For example, through an assurance of compliance that is approved by the Depart-
ment’s Office for Human Research Protections (OHRP), an institution pledges to
conduct its HHS-funded or supported research in accordance with the human sub-
jects protections of 45 CFR part 46. An institution also may voluntarily extend its
assurance to apply to all human subjects research it conducts regardless of funding
source.
In addition to assurances of compliance required by the HHS regulations at 45
CFR part 46, the HHS and FDA regulations also contain a number of other require-
ments for institutions engaged in HHS-conducted, -supported, or FDA regulated re-
search involving humans, including requirements relating to, for example, IRB
membership and procedures, criteria for IRB approval of research, suspension or
termination of IRB approval of research; and general requirements for informed con-
sent.
Additional Protections for Children Involved in Research
Children have long been recognized as a special and vulnerable population, and
are accorded special protections in many areas, including research. In 1983, HHS
adopted additional protections for children involved as subjects in research at 45
CFR part 46, subpart D, and in April 2001, FDA adopted similar requirements for
children under an Interim Final Rule, 21 CFR part 50, subpart D, Additional Safe-
guards for Children in Clinical Investigations.
When a proposed research study involves children and is supported or conducted
by HHS funding, the research institution’s IRB must take into consideration the
special regulatory requirements that provide additional protections for the children
who would be involved in research. If the proposed research involves FDA-regulated
products, then FDA’s parallel regulations would apply.
Both the HHS’ and FDA’s Subpart D regulations permit IRBs to approve three
categories of research or clinical investigations involving children as research sub-
jects:
45 CFR 46.404 and 21 CFR 50.51 — Research or clinical investigations not involving
greater than minimal risk to the children. To approve a research study or clinical
investigation in this category, the IRB must make the following determination:
• the research or clinical investigation presents no greater than minimal risk to
the children.
45 CFR 46.405 and 21 CFR 50.52 — Research or clinical investigations involving
greater than minimal risk but presenting the prospect of direct benefit to the indi-
vidual child subjects. To approve a research study or clinical investigation in this
category, the IRB must make the following determinations:
• the risk is justified by the anticipated benefits to the subjects;
• the relation of the anticipated benefit to the risk presented by the study is at
least as favorable to the subjects as that provided by available alternative ap-
proaches.
45 CFR 46.406 and 21 CFR 50.53 — Research or clinical investigations involving
greater than minimal risk and no prospect of direct benefit to the individual child
subjects, but likely to yield generalizable knowledge about the subject’s disorder or
13
condition. In order to approve a research study or clinical investigation in this cat-
egory, the IRB must make the following determinations:
• the risk of the research or clinical investigation represents a minor increase
over minimal risk;
• the intervention or procedure presents experiences to the child subjects that are
reasonably commensurate with those inherent in their actual, or expected med-
ical, dental, psychological, social, or educational situations;
• the intervention or procedure is likely to yield generalizable knowledge about
the subject’s disorder or condition which is of vital importance for the under-
standing or amelioration of the disorder or condition.
A fourth category of research or clinical investigation requires a special level of
HHS review beyond that provided by the IRB:
45 CFR 46.407 and 21 CFR 50.54 — Research or clinical investigation that the IRB
believes does not meet the above eategories of the HHS or FDA regulations, but finds
that the research presents a reasonable opportunity to further the understanding, pre-
vention, or alleviation of a serious problem affecting the health or welfare of children.
The research or clinical investigation may proceed only if the following conditions
are met:
• the IRB finds and documents that the research or clinical investigation presents
a reasonable opportunity to further the understanding, prevention, or allevi-
ation of a serious problem affecting the health or welfare of children; and
• the HHS Secretary and/or FDA Commissioner, after consultation with a panel
of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law)
and following an opportunity for public review and comment, determines either:
• that the research in fact satisfies one or more of the above categories of the
HHS or FDA regulations (i.e., 45 CFR 46.404, 46.405, or 46.406 under the
HHS regulations, and 21 CFR 50.51, 50.52, or 50.53 under the FDA regula-
tions) or;
• that the following conditions are met:
• the research or clinical investigation presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children;
• the research or clinical investigation will be conducted in accordance with
sound ethical principles.
In all cases noted above (i.e., 45 CFR 46.404, 46.405, 46.406, and 46.407), the IRB
must ensure that adequate provisions have been made for soliciting permission of
parents or legal guardians and the assent of the children, to the extent required by
HHS and FDA regulations.
Additional Protections for Children Who are Wards
The HHS and FDA regulations also include a provision in subpart D that provides
additional protections for children who are wards of the State or any other agency,
institution, or entity. These special protections for wards apply to two categories of
research or clinical investigations: (1) research or clinical investigations that involve
greater than minimal risk and no prospect of direct benefit to the individual child
subjects involved in the research or clinical investigation (research/clinical investiga-
tions approved under 45 CFR 46.406 or 21 CFR 50.53); or (2) research or clinical
investigations determined by the IRB not to meet the conditions of the HHS regula-
tions at 45 CFR 46.404, 46.405, or 46.406, or FDA’s regulations at 21 CFR 50.51,
50.52, or 50.53, but found to present a reasonable opportunity to further the under-
standing, prevention, or alleviation of a serious problem affecting the health or wel-
fare of children (research/clinical investigation approved under 45 CFR 46.407 or 21
CFR 50.54).
Before children who are wards of the State or any other agency, institution, or
entity can be included in either of the two categories of research or clinical inves-
tigations described above, the research must meet the following conditions:
• the research must be either related to the children’s status as wards; or con-
ducted in schools, camps, hospitals, institutions, or similar settings in which the
majority of children involved as subjects are not wards;
• and the IRB must require appointment of an advocate for each child who is a
ward, in addition to any other individual acting on behalf of the child as guard-
ian or in loco parentis.
One individual may serve as advocate for more than one child, and must be an
individual who has the background and experience to act in, and agrees to act in,
14
the best interests of the child for the duration of the child’s participation in the re-
search. The advocate should represent the individual child subject’s interests
throughout the child’s participation in the research. The HHS and FDA regulations
further require that the advocate not be associated in any way (except in the role
as advocate or member of the IRB) with the research, the investigator(s), or the
guardian organization.
HHS Compliance Oversight Activities
Due to the nature of the research that is subject to the HHS and FDA regulations,
each entity has developed its own system to respond to complaints and monitor com-
pliance with its regulations. These activities are complementary, and the results are
shared between OHRP (implementing the HHS regulations) and FDA.
OHRP
OHRP’s compliance oversight activities can be divided into three major categories:
(1) for-cause compliance oversight investigations; (2) not-for-cause compliance over-
sight surveillance evaluations; and (3) review and analysis of institutional reports
of noncompliance, unanticipated problems involving risks to subjects, or suspensions
or terminations of IRB approval of research.
For-Cause Compliance Oversight Investigations
OHRP initiates for-cause compliance oversight investigations in response to sub-
stantive written allegations or indications of noncompliance with the HHS regula-
tions for the protection of human subjects. Until recently, nearly all of OHRP’s com-
pliance oversight activities involved for-cause compliance oversight investigations.
Institutions engaged in human subject research that is conducted or supported by
HHS must provide written Assurances of Compliance to HHS describing the means
that they will employ to comply with the HHS Regulations. OHRP approves these
Assurances on behalf of the HHS Secretary. An Assurance approved by OHRP com-
mits the institution(s) and its personnel to full compliance with the HHS regula-
tions. In carrying out its oversight responsibility, OHRP evaluates all substantive
written allegations or indications of noncompliance with the HHS regulations de-
rived from any source.
OHRP holds accountable and depends upon institutional officials, committees, re-
search investigators, and other agents of the institution to assure conformity with
the institution’s Assurance and, thus, with the regulations. Only through the part-
nership established by the Assurance can the shared responsibility to protect the
rights and welfare of human subjects be discharged in accordance with Section 491
of the Public Health Service Act.
Sequence of Events for an OHRP For-Cause Compliance Oversight Inves-
tigation
The typical sequence of events to be followed in an OHRP compliance oversight
evaluation is as follows:
1. OHRP discovers or receives a substantive written allegation or indication of
noncompliance with the HHS Regulations (45 CFR Part 46).
2. OHRP determines that it has jurisdiction in the matter on the basis of HHS
support and/or an applicable Assurance of Compliance.
3. Upon confirmation that it has jurisdiction, OHRP initiates a compliance over-
sight investigation by writing to appropriate institutional officials to advise
them of OHRP’s investigation and to request that the institution investigate
the matter and report back to OHRP by a specified date. Activities expected
of the institution are explained in writing initially and at appropriate times
during the course of the evaluation. Except in rare circumstances when sound
ethics dictates the need to act immediately, OHRP takes no action against any
institution without first affording the institution an opportunity to offer infor-
mation which might refute indications of noncompliance or to develop satisfac-
tory corrective actions if the allegations or indications of noncompliance are
substantiated.
4. OHRP evaluates the institution’s report and any other pertinent information
to which it has access. OHRP may (a) request that the institution submit addi-
tional information in writing; (b) conduct telephone interviews with institu-
tional officials, committee members, and/or research investigators; or (c) con-
duct an on-site evaluation of protections under the applicable Assurance of
Compliance.
5. OHRP issues in writing a determination for each evaluation to appropriate in-
stitutional officials. The determination letter to the institution summarizes (i)
findings of noncompliance with the HHS Regulations, if any; and/or (ii) the cor-
rective actions proposed and/or implemented by tbe institution that appro-
15
priately address the findings of noncompliance. In such circumstances, any
complainant(s) are ordinarily informed in writing of OHRP’s determination
upon completion of its investigation.
6. An OHRP determination letteris made accessible on the OHRP website http://
www.hhs.gov/ohrp) once the document has been requested under FOIA, or ten
working days after the document is issued to the institution, whichever occurs
first.
7. An institution may request review by the Director of OHRP of determinations
and findings resulting from a compliance oversight evaluation.
Possible Outcomes of an OHRP For-Cause Compliance Oversight Investiga-
tion
Corrective actions based on compliance oversight investigations are intended to
remedy identified noncompliance with the HHS regulations and to prevent reoccur-
rence. Because each case is different, OHRP tailors its corrective actions to foster
the best interests of human research subjects, and to the extent possible, the insti-
tution, the research community, and HHS. Most compliance oversight evaluations
and resultant corrective actions are resolved at the OHRP level. In some instances,
however, OHRP recommends actions to be taken by other HHS officials.
OHRP’s compliance oversight evaluations may result in one or more of the fol-
lowing outcomes:
1. OHRP may determine that protections under an institution’s Assurance of
Compliance are in compliance with the HHS Regulations.
2. OHRP may determine that protections under an institution’s Assurance of
Compliance are in compliance with the HHS Regulations but that rec-
ommended improvements to those protections have been identified.
3. OHRP may determine that protections under an institution’s Assurance of
Compliance are not in compliance with the HHS Regulations and require that
an institution develop and implement corrective actions.
4. OHRP may restrict its approval of an institution’s Assurance of Compliance.
Affected research projects continue to be supported by HHS only if the terms
of the restriction are being satisfied. Examples of such restrictions include, but
are not limited to:
a. suspending the Assurance’s applicability relative to some or all research
projects until specified protections and corrective actions have been imple-
mented;
b. requiring prior OHRP review of some or all research projects to be con-
ducted under the Assurance;
c. requiring that some or all committee members and institutional officials, as
well as investigators conducting research under the Assurance, receive ap-
propriate human subject education; and
d. requiring special reporting to OHRP.
5. OHRP may withdraw its approval of an institution’s Assurance of Compliance.
The institution’s research projects cannot be supported by any HHS component
until an appropriate Assurance is approved by OHRP.
6. OHRP may recommend to appropriate HHS officials that:
a. an institution or an investigator be temporarily suspended or permanently
removed from participation in specific projects, and/or
b. peer review groups be notified of an institution’s or an investigator’s past
noncompliance prior to review of new projects.
7. OHRP may recommend to HHS that institutions or investigators be declared
ineligible to participate in HHS-supported research, known as Debarment.
Note that a suspension of eligibility for Federal funding may precede a Debar-
ment. If OHRP makes this recommendation, the Debarment process will be ini-
tiated in accordance with the procedures specified at 46 CFR Part 76. Any De-
barment is Government-wide, and not just applicable to HHS funding.
Not-for-cause Compliance Oversight Surveillance Evaluations
In 2001 OHRP initiated a not-for-cause compliance oversight surveillance pro-
gram. Under this program, OHRP selects institutions without any active for-cause
compliance oversight investigations and conducts an assessment of their human
subject protection programs. OHRP initiates a not-for-cause compliance oversight
evaluation by writing to appropriate institutional officials at a selected institution
to advise them of OHRP’s evaluation and to request that the institution provide
OHRP by a specified date with IRB records and other documents relevant to the
institution’s program for the protection of human subjects. In most cases, OHRP
conducts a site visit following review of the requested documents. OHRP issues a
determination in writing for each evaluation to appropriate institutional officials.
16
The determination letter to the institution summarizes: (i) findings of noncompli-
ance with the HHS regulations, if any; and/or (ii) the corrective actions proposed
and/or implemented by the institution that appropriately address the findings of
noncompliance. The possible outcomes of a not-for-cause compliance oversight eval-
uation are the same as for a for-cause investigation.
FDA
FDA’s compliance oversight activities dovetail with some of OHRP’s activities de-
scribed above. FDA has developed a Good Clinical Practice Program, which has
prominently displayed the process for filing complaints with the Agency. This is
available on FDA’s website at: http://www.fda.gov/oc/gcp/complaints.html. Generally,
complaints are investigated and handled by the particular Center within FDA (e.g.,
involving Drug Evaluation and Research; Devices; Biologies, etc.) responsible for the
study, which would also be the most knowledgeable about the issues involved in the
complaint.
FDA’s Bioresearch Monitoring Program
FDA developed its Bioresearch Monitoring Program (BIMO Program) to ensure
the protection of the rights, safety, and welfare of human research subjects and the
quality and integrity of data submitted to the agency. The BIMO Program encom-
passes all FDA product areas: drugs, biological products, medical devices, radio-
logical products, foods, and veterinary products. Among other things, the BIMO Pro-
gram involves site visits to clinical investigators, sponsors, monitors, contract re-
search organizations, IRBs, nonclinical (animal) laboratories, and bioequivalence an-
alytical laboratories. FDA uses Compliance Policy Guide Manuals (CPGM) to in-
struct its field personnel on the conduct of inspectional and investigational activi-
ties. These are available at: http://www.fda.gov/oc/gcp/compliance.html.
FDA conducts IRB inspections to determine if IRBs are operating in compliance
with current FDA regulations and if the IRBs are following their own written proce-
dures. The FDA regulations pertinent to IRBs include 21 CFR Part 50 (Protection
of Human Subjects), Part 56 (Institutional Review Boards), Part 312 (Investiga-
tional New Drug Application), and Part 812 (Investigational Device Exemptions).
FDA inspections of IRBs generally fall into one of two categories:
• Surveillance inspections — periodic, scheduled inspections to review the overall
operations and procedures of the IRB; and
• Directed inspections — unscheduled inspections focused on the IRB’s review of a
specific clinical trial or trials. Directed inspections may result from a complaint,
clinical investigator misconduct, or safety issues pertaining to a trial or site.
During an inspection at the site of a clinical investigator, FDA personnel typically
verify:
• who performed various aspects of the protocol (e.g., who verified inclusion and
exclusion criteria, who obtained informed consent, who collected adverse event
data);
• the degree of delegation of authority (e.g., how the clinical investigator super-
vised the conduct of the study);
• where specific aspects of the study were performed;
• the accuracy of the data submitted;
• how accountability for the investigational product was maintained;
• how the monitor communicated with the clinical investigator; and
• how the monitor evaluated the study’s progress.
FDA personnel also audit the study data by comparing the data filed with the
Agency or the sponsor with all available records that support the data. These
records may come from the doctor’s office, hospital, nursing home, laboratories, and
other sources. FDA may also examine patient records that predate the study to find
out whether: the medical condition under study was in fact diagnosed; the study eli-
gibility criteria were met; and the patient received a possibly-interfering medication
before the study began. FDA personnel may also review records covering a reason-
able period after completion of the study to determine if there was proper follow-
up as outlined in the protocol, and if the clinical investigator reported all signs and
symptoms reasonably attributable to the product’s use.
After headquarters review, one of the following types of letters is typically sent
from the Center to the IRB or clinical investigator depending upon the type of in-
spection:
1. A letter that generally states that FDA observed no significant deviations from
the regulations. This letter does not require any response. Note that a letter
may not always be sent when FDA observes no significant deviations.
17
2. An informational or untitled letter that identifies deviations from regulations
and good clinical practices. This letter may request a response from the recipi-
ent. If FDA requests a response, the letter will describe what is necessary and
identify a contact person for questions.
3. A 'Warning Letter that identifies serious deviations from regulations needing
prompt correction and a formal written response to FDA. The letter will iden-
tify an Agency contact person for questions. For investigator inspections, FDA
may inform both the reviewing IRB and the study sponsor of the deficiencies
and advise the sponsor if the clinical investigator’s procedural deficiencies sug-
gest ineffective monitoring by the sponsor.
In addition to issuing these letters, FDA may take regulatory actions for serious
deviations from the regulations. FDA may disqualify the IRB, institution, or clinical
investigator. A disqualified clinical investigator is ineligible to receive investiga-
tional products. FDA may also place lesser administrative sanctions on the IRB.
Under the BIMO program, FDA conducts approximately 1000 inspections annu-
ally of all of thevarious parties that conduct or oversee clinical research studies (i.e.,
clinical investigators, sponsors, monitors, contract research organizations, and
IRBs). Of these inspections, about two-thirds are clinical investigator inspections,
approximately 250-300 are inspections of IRBs (mostly drawn from FDA’s inventory
of about 1600 IRBs identified as responsible for reviewing FDA-regulated research),
and the remainder are sponsor or monitor/contractresearch organization inspections.
For clinical investigations of drugs alone, FDA conducted approximately 75 inspec-
tions of studies involving pediatric subjects from 2001 to 2004.
Review and Analysis of Institutional Reports
The HHS and FDA regulations require that IRBs follow written procedures to en-
sure the prompt reporting to the IRB, appropriate institutional officials, and the
pertinent agency head (OHRP Director for research conducted under an OHRP-ap-
proved assurance or FDA Commissioner for research involving FDA-regulated prod-
ucts) of the following incidents:
1. any unanticipated problems involving risks to subjects or others;
2. any serious or continuing noncompliance with this policy or the requirements
or determinations of the IRB; and
3. any suspension or termination of IRB approval.
(See 45 CFR 46.103(b)(4)(iii) for HHS-conducted or-supported research and 21
CFR 56.108(b) for FDA-regulated research.)
When reviewing a report of an unanticipated problem, OHRP or FDA assesses
mostclosely the adequacy of the actions taken by the institution to address the prob-
lem. Likewise, when reviewing reports of non-compliance or suspension or termi-
nation of IRB approval, OHRP or FDA assesses most closely the adequacy of the
corrective actions taken by the institution. In particular, an assessment is made
whether or not the corrective actions will help ensure that the incident will not hap-
pen again, either with the investigator or protocol in question, or with any other
investigator or protocol. When appropriate, corrective actions are applied institu-
tion-wide.
Conclusion
We continue to address challenges posed by the threat of HIV/AIDS and are com-
mitted to basic and clinical research to strengthen the nation’s ability to cope with
this infectious disease. The protection of human subjects, including children, in clin-
ical trials has been and will remain a top priority for HHS. HHS is firmly com-
mitted to the protection of the rights and welfare of every individual who partici-
pates in human research consistent with sound ethical standards and regulatory re-
quirements.
Chairman HERGER. Thank you, Dr. Young. The gentleman from
California, Mr. Nunes, to inquire.
Mr. NUNES. Thank you, Mr. Chairman, and thank you for wel-
coming me to the Subcommittee. Welcome, Dr. Young. In relation
to some of the news reports that have been out there recently, do
we know whether any children in foster care today are partici-
pating in clinical trials? If so, do you know how many?
18
Dr. YOUNG. I do not have that information. We know that
across the National Institutes of Health (NIH) there are a number
of clinical trials ongoing and children participating, but I do not
have numbers of children in foster care that might be in that
group.
Mr. NUNES. Okay. Could that be something that you could find
out? Could you submit that to the Subcommittee if you do?
Dr. YOUNG. If we can find it through our survey information,
I will.
Mr. NUNES. Okay. Another question. Your testimony says that
the State child welfare agencies were strongly urged to reduce bar-
riers to foster children’s participation in such trials. In the early
days of the AIDS crisis, what were those barriers, and who strongly
urged State officials to reduce those barriers?
Dr. YOUNG. I think that the desire to reduce those came from
across the community. In those years, as I said in my testimony,
there was no treatment unless you were involved in a clinical trial.
This was an emerging disease, and treatments were just emerging
at that time, so there was wide support. The barriers included the
State laws and requirements that I mentioned in my testimony
that said only standard care could be given to individuals in foster
care. That prevented them from being enrolled, and the feeling was
that the children in foster care should have the same opportunity
to make a decision, an election or to have their wards do it for
them, to participate if they wanted to participate and get the value
and advantage of that trial.
Mr. NUNES. Thank you. Doctor. Thank you, Mr. Chairman.
Chairman MERGER. Thank you. The gentleman from Wash-
ington, Mr. McDermott, to inquire.
Mr. MCDERMOTT. Thank you. Dr. Young. Good testimony and
I would like to ask you a couple questions about the structuring of
the clinical trials. Is there anything in the NIH requirements that
require a State to have in place an advocacy requirement? Or can
any physician who wants to do a trial in whatever State send in
an application and operate within the laws of that State and be
considered acceptable to NIH? In other words, does NIH have a set
of standards that require that the State must fit?
Dr. YOUNG. The Office of Human Protection is the Eederal
agency, has a baseline set of requirements that must be adhered
to and that the IRB must follow. That deals with, as I said in my
testimony, the last two categories, those clinical trials where there
is more than a minimal risk involved. Under those circumstances,
then, an advocate needs to be appointed for children in foster care
to make the decision and ensure that the child is protected and
fully informed.
Mr. MCDERMOTT. The question then comes down to these — it
is always words. In your testimony, you said you may say that pro-
tection is not required if the research has minimal risk — minimal
being the operative word — or if it has the prospect of direct benefit.
Those again being the operative words. Who makes those decisions
as to what is minimal, what is direct benefit to the child? How is
that determined?
Dr. YOUNG. The Institutional Review Board has the responsi-
bility to approve all research protocols that are put forward by in-
19
vestigators. Most of those institutional review boards are under a
hospital, academic medical center or other place that also has the
responsibility to ensure that there is IRB compliance to that. There
is a set of Federal rules. There are then the requirements that the
IRB must consider in making a decision whether to approve the re-
search as well as any additional requirements that come from the
institution. Beyond that, there are a number of States that have
also passed laws that may — putting stronger requirements in place.
Mr. MCDERMOTT. Could it be possible today to have a child
brought into a clinical trial in a State where there was no require-
ment for advocacy for something — these AIDS drugs when we were
looking back at them in 1987 and 1988 and 1989, there was no
children’s research being done. What this was about is really the
first children’s research. How did anybody decide it was minimal
risk or that it was a direct benefit to the kids? How did they come
up — without an advocate — it would seem to me like you would
want to automatically have an advocate in something as new as
that.
Dr. YOUNG. Yes. There are two parts to your question. One is
the advocate and the situations more than minimal risk that there
must be an advocate. That is not to say, however, in all situations
there isn’t the State agency or a ward that is making decisions.
Somebody has to consent to it, and it has to be an informed con-
sent. It is only when the risk is more than minimal and the condi-
tions that I described in my testimony that, in addition to that, you
need a special advocate for the patient. Now, the second part of
that are the rules and requirements for research to make sure that
it is conducted properly. You need an advocate, but you need a re-
search protocol that is laid out that protects the individuals in that
trial, whether they are foster children, adults or children not in fos-
ter care.
Mr. MCDERMOTT. The reason I ask those questions, I can envi-
sion a situation in which a child care worker who is dealing with
AIDS cases coming out of a city hospital or whatever may have 30,
40 kids or 60 kids, and to expect the child care worker to be on
top of the case, it seems to me, sets the ground for kids slipping
through the cracks as they do in a variety of different ways in the
system. I wonder if you — , if you don’t have minimum requirements
for how many — or maximum requirements for how many kids a
worker is responsible for, to expect he or she to cover 60 kids, all
of whom are in AIDS treatment programs all over the city or what-
ever, it seems like you would want to have somebody for each kid
to look after or at least — you can see my problem.
Dr. YOUNG. I do, and let me try to explain it one more time.
There is an advocate appointed for the children in foster care. That
advocate is different under the requirements. That advocate is dif-
ferent than the State agency. That advocate could be part of the
PRB. It could be somebody who is particularly interested in kids.
Each advocate might have one, two or three kids. This is not the
caseworker who is the advocate under those situations. The advo-
cate is somebody in addition to the State foster care agency.
Mr. MCDERMOTT. So, this is a volunteer who comes in and gets
involved in the advocacy program in the local State agency and has
20
three kids with maybe no background whatsoever in the specific
issues.
Dr. YOUNG. No. There are requirements also regarding the ad-
vocacy that are part of the PRB requirements, that the advocate
have the knowledge and be familiar with the condition. It is not
anyone off the street can come in and be an advocate.
Mr. MCDERMOTT. I wasn’t implying that they were just off the
street. This is a specific, very difficult decision to put a kid into a
treatment case., the reason I am sensitive about this is, we have
a cancer center in Seattle. I have seen what happens when you are
using advanced treatments in cancer and then people later say,
well, I didn’t know the risks. There is a whole lot of responding
backward and forwards about what people knew. In this case, you
have a kid who doesn’t have a clue what is going on. He is being
brought or she is being brought, put into the system, and I am
wondering how you know, how you can guarantee that that kid has
somebody who really understands what is going on?
Dr. YOUNG. I understand your question. That is the issue of
what is informed consent, and how much knowledge must you have
to achieve informed consent? That question is directly relevant to
all research, and particularly to research on kids, and then foster
kids add an additional level and layer. So, there is a responsibility
to attempt to communicate as clearly as one can, but as you know,
in lay terms, it is sometimes difficult to communicate fully and yet
keep a message simple that people can understand. That is a chal-
lenge for this kind of research. It is a challenge for cancer research
in children, any kind of research that has substantial risks but
substantial rewards.
Chairman HERGER. The gentleman’s time has expired. The gen-
tleman from Colorado, Mr. Beauprez, to inquire.
Mr. BEAUPREZ. I thank the Chairman, and I thank Dr. Young
as well for his testimony and for being here with us today. I think
the gentleman from Washington has probably already begun going
down a path that is of most concern to the Subcommittee. Let me
stay in that track for a minute. Doctor, as I first heard about this
issue, I guess one of the knee-jerk reactions would be, well, let us
just not submit foster children to clinical trials. That is not really
where we want to go. Is it? I am guessing that the numbers — they
are staggering numbers, frankly, that you shared with us of 16 to
22 percent of children now with HIV back in 1990 were foster care
children. We would actually want them to have access to some of
the state-of-the-art treatment. I am assuming that that is correct?
Dr. YOUNG. Yes, sir, I agree with you. They should have the op-
portunity to make their — their guardians should have the oppor-
tunity to make the decision if they wish to participate. If they
choose not to, that is fine. To exclude them from even having the
opportunity to make that decision I don’t believe is correct.
Mr. BEAUPREZ. Unfortunately, sometimes, it is that very popu-
lation that disproportionately is burdened with some of the dis-
eases we would like to get a handle on.
Dr. YOUNG. That was particularly true back in the late eighties
for HIV/AIDS when clinical research, clinical trials was the only
opportunity, the only hope for treatment.
21
Mr. BEAUPREZ. The question becomes who then best make this
decision or assist the child in making this decision and that is what
I want to probe a little bit more with you. I contacted some of our
folks back in Colorado who wrestle with this, and the idea of the
child advocate seemed to make perfect sense to me: Let us get
someone out there who has maybe even met some standard across
some threshold on the per chance that we have got a foster par-
ent — ^because we hear about these tragic cases where the foster
parent was not the best choice for the child’s well-being, and we all
are traumatized by that, as the child who at least is traumatized.
What I found out is that, in the opinion at least of the medical pro-
fessionals back in my State, many, many, many times it is the fos-
ter parent on their way to becoming the adoptive parent because,
apparently, we have a very high percentage of exactly that that
happens, that may well be the person with the child’s best interest
at heart. It crosses my mind that we would not want to categori-
cally preclude foster parents from the process, either. Would that
be a fair assessment?
Dr. YOUNG. Yes, I think that is a fair assessment. We are bal-
ancing a lot of different factors here. There is also the biologic par-
ent and what role they should have. Some States allow both or
even require both be appointed. Those kinds of decisions in many
cases are best made locally by the people who know the State,
know the procedures, know what is going on there. There is room
for Colorado to make modifications in keeping with the broad set
of Federal basic requirements.
Mr. BEAUPREZ. Which gets me to, I guess, the next question I
would raise of you. I understand that we have got Federal guide-
lines, but as you testified just moments ago to us, really it is up
to State and local and many cases city and/or county officials to not
only apply the rules, but in some cases, I suppose, adjust the rules.
They have some local flexibility. Is there more than ought to be
done at the Federal level to protect certainly the interests of the
child? I will emphasize again, the interest of the child can go both
ways. We certainly don’t want them to get put into a clinical trial
situation that we would all think was inappropriate, too great a
risk, but we also don’t want to somehow subjectively preclude them
from having the opportunity to have access to the latest state-of-
the-art medical techniques. What should we be doing at the Fed-
eral level?
Dr. YOUNG. I think your points are good ones. I think one of the
things the Department will be doing very closely is, following this
hearing, following what you are learning and hearing from the wit-
nesses. We are not aware of any changes that we believe need to
be made. If they are identified, we will be very happy to consider
them and make a decision as how best to proceed. We share with
you the concern about the adequate protection of foster children. At
the same time, the opportunity to let them participate and get the
advantage of clinical research, if that is theirs and their guardian’s
decision.
Mr. BEAUPREZ. If there is a second left, can you comment on
the difference between assent and consent.
Dr. YOUNG. Consent means that you have the legal authority to
agree to participate, in this case in research. A minor, generally
22
under 18 , legally cannot consent by law, but the minor can assent.
There are requirements that the subjects need to assent to. That
is to say, yes, I am willing to do this. That doesn’t carry the legal
weight of consent, but it says that the minor has agreed to partici-
pate. One is a legal concept; one is a concept of agreeing.
Mr. BEAUPREZ. Thank you. Thank you, Mr. Chairman.
Chairman MERGER. Thank you. The gentleman from California,
Mr. Becerra, to inquire.
Mr. BECERRA. Thank you, Mr. Chairman. Dr. Young, thank you
for being with us and thank you for your testimony. Let me ask
a preliminary question, because I am not real familiar with how
this all works. How much knowledge does HHS have, first of all,
with regard to the number of foster care children who participate
in these different studies?
Dr. YOUNG. We do not have good detailed information on that
to answer that question.
Mr. BECERRA. Let me back up even further then. We know
there is value in some of the research and the clinical trials that
occur, and we know that, oftentimes, we want to be able to help
children because they have so many years of life ahead of them if
we are able to do some good work and help them medically. At
what point do we believe that our responsibility by using taxpayer
dollars to help fund some of this research or these trials extends
to ensuring that we know who those who are conducting the trials
or the research are when they approach these children, especially
foster children, are trying to protect their rights?
Dr. YOUNG. That is where the Department’s compliance activi-
ties come into place. As I said, we will follow up where we hear
reports. We will do random surveys periodically. We will talk to the
State agencies, but that then becomes an issue of Federal checking,
investigation, if you would, of compliance to identify problems and
to correct those problems.
Mr. BECERRA. Now, how large is your Office of Human Re-
search Protection?
Dr. YOUNG. I am sorry. I will have to submit that for the
record. I do not know that.
Mr. BECERRA. Any idea? How many folks do you have to inves-
tigate?
Dr. YOUNG. I am not in the Office of Human Protection and Re-
search. I am in HHS assistant secretary for planning and evalua-
tion. I just don’t have that information.
Mr. BECERRA. Do you have anybody here with you who might
be able to answer that question?
Dr. YOUNG. I don’t believe so.
Mr. BECERRA. Well, give me your sense from what you know
of how much — how much in resources do we have to try to provide
some surveillance, some oversight to ensure that, in the first in-
stance, those who are using Federal tax dollars to conduct their re-
search or these clinical trials are at least trying to follow Federal
law? Certainly, there must be State law that is implicated because
the State has custody of these foster care children. Do you have
any sense of what kind of resources we spend?
Dr. YOUNG. I am sorry, sir, I just don’t. As I say, that is not
an issue that I looked at in preparation for this hearing.
23
Mr. BECERRA. Mr. Chairman, perhaps what we could do is ask
Dr. Young to see if HHS could get back to us with some informa-
tion.
Dr. YOUNG. I would be happy to.
Mr. BECERRA. To get a better sense, because I suspect one of
the problems we have is you all just don’t have the resources to try
to be more vigilant about how these clinical trials or this research
is being conducted. So, the first thing is, we have to get a handle
on whether or not folks are following through and at least abiding
by their commitments when they obtain Federal funding to follow
Federal law. I suspect that the State probably would respond the
same way and all the different States would respond the same way,
saying they probably don’t have enough money to probably do some
oversight over their wards, the children that are within their cus-
tody through the foster care system. Let me ask. In terms of the
type of oversight that you might think would be helpful — ^because
we can’t have someone overseeing every clinical trial or every bit
of research that we fund. Is there some guidance you can give us
on what we should be looking to see HHS do when it comes to pro-
tecting the interest of that child as we try to promote their well-
being?
Dr. YOUNG. First, let me remind you again that the first level
of oversight is at the local institution, and there is substantial over-
sight at that level; that these research protocols are on patients
who have physicians taking care of them, who may or may not be
involved in the research, who provide oversight. The Institutional
Review Board will provide oversight.
Mr. BECERRA. Dr. Young, how do we ensure that that first in-
stance of oversight is occurring? We are giving Federal tax dollars.
Most of the research will be done locally in a particular State.
States have obligation to take care of these wards, the wards of the
State or kids who are in foster care. How do we ensure that, when
we release those Federal dollars, that in fact, at that local level,
that oversight will occur? While locally there is more control and
responsibility for the child, I think all of us would still believe that
we should not relinquish whatever rights we have to ensure that
that child is taken care of or handled properly.
Dr. YOUNG. I absolutely agree with you. There is the level that
is local at the physician, the physician caring for the patient. There
is the Institutional Review Board. There is the institution, that
may be a hospital, in which the Institutional Review Board is
housed. There are the State agencies on foster care, and then there
is the Federal rules on compliance and on investigations that flow
from that compliance. We will get back to you with the information
you asked in terms of the size of the agency budget, and so forth.
Mr. BECERRA. Mr. Chairman, may I ask one last question,
quick question?
Chairman HERGER. The gentleman’s time has expired.
Mr. BECERRA. Fifteen seconds.
Chairman HERGER. One other quick question.
Mr. BECERRA. Just a quick comment. Then maybe what we can
do is, if you can tell us if there are any consequences for those who
we have found to not be following Federal regulations or even State
law in the — as they use these Federal tax dollars to do their re-
24
search or trials, clinical trials, to see how we can try to get to those
who aren’t following through with their own responsibility.
Dr. YOUNG. A very quick answer. Yes, there are ways to do
that. The FDA regulations in fact lay out, specifically, sanctions
that can be brought toward those who do not follow the rules.
Mr. BECERRA. Thank you. Thank you, Mr. Chairman.
Chairman MERGER. Thank you. The gentleman from Michigan,
Mr. Camp, to inquire.
Mr. CAMP. Well, thank you, Mr. Chairman. I want to follow up
on that compliance line of questioning that Congressman Becerra
brought up. I realize you can’t talk about ongoing HHS investiga-
tions, but can you tell us about any previous findings of noncompli-
ance with HHS regulations involving children in foster care and
their participation in clinical trials?
Dr. YOUNG. I cannot. I simply don’t have that information as
to the past history of any investigations and the outcome of those.
Mr. CAMP. What happens if an institution is found to be out of
compliance in such cases? Are you aware of that?
Dr. YOUNG. Yes. Individuals cannot be allowed to participate in
research if the findings are egregious enough from the research
side. Or the Institutional Review Board will be asked to restructure
and to change its membership to get a better mix of membership
that is more appropriate to dealing with the problems so that there
are a number of ways that there can be changes made if there are
deficiencies going on. The ultimate is, of course, not funding the re-
search.
Mr. CAMP. Has that actually happened? Have institutions been
suspended from receiving Federal funding or declared ineligible to
participate?
Dr. YOUNG. As I said a moment ago, I simply don’t know the
answer to that question.
Mr. CAMP. All right, so we don’t know what institutions. For
what reasons?
Dr. YOUNG. There may be some information on that that I sim-
ply don’t have.
Mr. CAMP. All right, to Congressman Nunes, I believe your re-
sponse was that you don’t have any knowledge of the number of
children in foster care in clinical trials.
Dr. YOUNG. That is correct.
Mr. CAMP. Are you making attempts to find that out? Is there
a process in place to determine that? Or is that not something you
are pursuing?
Dr. YOUNG. The Chairman mentioned the survey that is ongo-
ing, and I will have to look in more detail to see what the content
of that survey will be.
Mr. CAMP. All right. Do we have any idea of whether there are
any States that require independent advocates for children to be —
any foster children who might be participating in the clinical
trials?
Dr. YOUNG. The anecdotal reports, including those in the press,
suggested that there are some States. I do not have any primary
knowledge on that question one way or the other.
25
Mr. CAMP. Federal regulations require advocates under certain
circumstances, do you know how many persons have served as ad-
vocates for children in clinical trials? Do you know of any number.
Dr. YOUNG. I do not have information on that.
Mr. CAMP. I guess what I am trying to get at is, how do we
know about the nature of the trials, the relative risk and benefit
for children without that information?
Dr. YOUNG. We are depending primarily, again, at the local
level, on the Institutional Review Boards, the institutions, and the
oversight that is provided there. We in turn then at the Federal
level will do the investigations as currently being reported in the
press and the compliance activities. There is a lot of reliance on
what is happening locally, the medical and research community at
the local level.
Mr. CAMP. The Institutional Review Boards are charged with
determining how and under what conditions children may partici-
pate in those trials. To what extent does that information get back
to HHS?
Dr. YOUNG. We don’t routinely collect information from the
IRBs. We have the broad set of rules, and we will check compliance
overall, but we will not collect information.
Mr. CAMP. All right. Thank you, Mr. Chairman.
Chairman MERGER. Thank you. Dr. Young, there were several
questions that Mr. Camp inquired of and I believe another Mem-
ber. So, would you mind responding in writing to the Subcommittee
on that? Our record will be open for 2 weeks.
Dr. YOUNG. Yes.
Chairman MERGER. Thank you. The gentleman from California,
Mr. Stark, to inquire.
Mr. STARK. Dr. Young, I am sorry I missed your testimony, but
we did have a chance to review it. I want to go back to this, as I
just heard in the few minutes that you have been responding to
questions, that you feel that having an independent advocate for
each foster child is taken care of locally, but in the Federal regula-
tions, the rules state, for example, that in experiments involving
prisoners, the IRB has to include a prisoner advocate to protect the
rights of prisoners. Why shouldn’t children get that same protec-
tion?
Dr. YOUNG. The same rules apply to children as to
Mr. STARK. No.
Dr. YOUNG. Well, just a moment. As to prisoners, there, the
rules are that, where there is a frequent IRB interaction, if there
is one prison study and a lot of others that are not, the IRB does
not have to. They are encouraged to have people who understand
and know the situation, whether it is children or prisoners, but
they do not have to have a prisoner if there is a single research
protocol that has gone forward through the IRB.
Mr. STARK. Well, I am not at all sure that you and the inspector
of the GAO agree, but let us come back. I am going to stick with
my assertion from the CRS that the Federal regulations in fact do
require that the IRB has to include a prisoner advocate if there is
in fact a prisoner involved in the study. Now, we can find that out
subsequently, and I am sure that your knowledge of the law is su-
perior to mine. Based on that, why in the world wouldn’t it be —
26
what would be wrong with requiring an advocate for a child, for a
foster care child in these experiments?
Dr. YOUNG. The current rules do require an advocate. Now, I
am making a distinction between the IRB’s composition and the ad-
vocate. The advocate requirement is above and beyond the IRB,
and the advocate requirement is there when there is more than
minimal risk
Mr. STARK. Okay.
Dr. YOUNG. When there is more than minimal risk and where
the value of it is not commensurate with that. There needs to
be
Mr. STARK. Who decides whether there is more than minimal
risk?
Dr. YOUNG. The IRB.
Mr. STARK. You don’t think it would be necessary on the IRB
to have a child’s advocate?
Dr. YOUNG. If the IRB is involved in looking at a substantial
number of research protocols, for example, in a pediatric hospital,
then, yes, I think that is a very reasonable requirement.
Mr. STARK. What about any program in which a foster child is
involved? Why shouldn’t the IRB include an advocate for that
child?
Dr. YOUNG. If there is a — let me make sure I understand your
question. If there is a research protocol going through that is no
more than minimal risk, then the IRB will look at it. That IRB
does not need to have a pediatrician on the IRB, and there is no
requirement separate from that for an advocate. I think that gives
adequate protection.
Mr. STARK. Dr. McDermott, would you yield to me? Do you
think that is adequate protection?
Mr. MCDERMOTT. I don’t know. Let me think about it.
Mr. STARK. Okay. I am talking to a pediatrician in his former
life.
Mr. MCDERMOTT. Psychiatrist.
Mr. STARK. Well, pediatric psychiatrist, as I recall, and it just
troubles me that my suspicion is that we have more concern about
prisoners and more protections than we do for kids. We have seen
so many examples of minimal risk in drug testing, for instance. We
have got to bring the pharmaceutical industry to heel. They have
been testing things, you know, giving drugs to kids without involv-
ing them in tests. My feeling is that children, and particularly chil-
dren in foster care who perhaps have a higher — we have an ad-
verse selection there. I would guess that it is fair to suggest, Mr.
Chairman, that children in foster care children tend to be poorer
and perhaps have had poorer health care for whatever reason as
a population and would be more apt to show up in many of these
studies. I am worried that the tendency is to say, well, it is okay
to let the local people take care of that, because I am not sure that
all local jurisdictions would be — for instance, here in Washington,
D.C., and I conclude, they can’t find half the kids in foster care.
How would you like to have a foster care child from the District
of Columbia when its present foster care system is in a State of up-
heaval and say. Gee, they will take care of it? I don’t think I be-
lieve that. I would rather you doing it. I trust you.
27
Chairman MERGER. The gentleman’s time has expired. Dr.
Young, what do Eederal regulations require in terms of the naming
of independent advocates for foster children in clinical trials?
Dr. YOUNG. If the clinical trial involves more than minimal risk
and if the value of the clinical trial is not commensurate with that
for the individual patient, then the advocate must he appointed to
make the decision for the child in foster care.
Chairman MERGER. Is there evidence to suggest that children
with advocates who participated in these trials had better out-
comes, they live longer, had better health, are still alive today than
those without advocates?
Dr. YOUNG. I don’t believe there is any information on that sub-
ject. I would not see why there would be any particular difference
related to the variable of an advocate only. The advocate is there
for a decisionmaking of yes or no. It is the ethical structure of the
clinical trial that determines whether it is appropriate, number
one, for the individual to even be eligible for the trial. So, I don’t
know information of that, but I would not expect that that would
be a variable.
Chairman MERGER. Well, I thank you very much. Dr. Young,
for your testimony. With that, I would like to invite our next panel
to have seats at the table. On this panel we will be hearing from
Dr. Alan Eleischman, senior advisor at the New York Academy of
Medicine; Ms. Roberta Marris, Deputy Secretary of the Wisconsin
Department of Mealth and Eamily Services; Dr. Marjorie Speers,
executive director of the Association of Accreditation of Muman Re-
search Protection Programs; and Dr. Moira Szilagyi, on behalf of
the American Academy of Pediatrics. Dr. Eleischman.
STATEMENT OF ALAN ELEISCHMAN, M.D., SENIOR ADVISOR,
THE NEW YORK ACADEMY OF MEDICINE, NEW YORK, NEW
YORK
Dr. ELEISCMMAN. Mr. Chairman, Subcommittee Members,
thank you for inviting me. My name is Alan Eleischman. I am a
physician, pediatrician and medical ethicist. My professional back-
ground and expertise is in the written testimony, but I speak today
as and individual. Clinical research with therapeutic intent involv-
ing children in foster care is an ethical imperative and can, and
was, performed in an appropriate manner fully consistent with
good ethical practice and compliant with Eederal regulations that
govern research. In order to understand the issue of enrollment, I
will share with you some of the data that Dr. Young did as well
about the late eighties and early nineties in MIV care and treat-
ment of children.
Twenty-five percent of babies born to women who were MlV-in-
fected developed MIV, AIDS was universally fatal in children, and
25 percent of infected children died by age 5. Many of the young
children with MIV were boarder-babies, were in foster care because
they had become orphans due to the death of their mothers or be-
cause their mothers were impaired. Great strides were being made
at that time with new drugs developed for the treatment of MIV
and AIDS and its complications, but initial trials were only in
adults. These new treatments were not available for children, and
28
there weren’t any pediatric formulations of the drugs available to
the doctors caring for such children.
The National Institutes of Health developed clinical research
trials, and that is our first step of safety for the children in order
to study the effectiveness of the various new treatments in chil-
dren. Some of the drugs had potential for side effects. They were
serious drugs. They were against a serious virus, but those possible
risks were far outweighed, as doctors would know, by the potential
therapeutic benefits. In New York City, the agency responsible for
supervision of foster children developed mechanisms that made en-
rollment of foster children in clinical trials possible, because it
would have been unjust not to offer these children the very best
prospect of life-saving treatments. The first protection was that in-
dividual medical institutions conducted the trials only after Institu-
tional Review Board prospective review and approval.
The consent of biologic mothers or legal guardians was obtained
when possible. An agency permission on an individual basis was re-
quired before the child could be enrolled in the trial, and foster
parents were involved in these discussions because of their need to
administer treatments and bring children back for follow-up visits
to the hospital in order to be successful in the trials. The appoint-
ment of advocates for the children, while a laudable procedural ap-
proach, was not required. We did choose that approach in the
Bronx, but we were not required to do that by the Federal regula-
tions.
Today, pediatric AIDS treatment in the United States is dif-
ferent, because of clinical trials there are effective treatments to
prevent children from becoming infected in utero, and there are ef-
fective treatments to prevent children from — there are effective
standard treatments for the smaller number of children who are
now infected. AIDS in children has become a chronic disease with
less than 1 percent mortality each year for children treated in
AIDS centers in the United States. Children in foster care who are
infected with AIDS today are getting standard treatments and are
rarely participating in clinical trials because it is no longer a mat-
ter of life and death. There may be a time in the future, perhaps
with the emergence of a new dreaded disease, when we will once
again be faced with the critical need to enroll foster children in
clinical trials in order to provide needed life-saving treatments. Our
past experience with HIV and AIDS and the present Federal regu-
latory structure on research allows us to do that, if we need to.
In conclusion, those of us involved in the treatment of children
infected with HIV knew that a large percentage of our patients
were poor, minority children, and many of those children were in
foster care. We demanded the very best treatment for these vulner-
able children. The only way to provide it, in fact, to provide treat-
ment in HIV care to any child with AIDS, at that time was through
clinical trials. We enrolled children in treatment trials and gath-
ered information on the effects of the new drugs on children while
we attempted to save and enhance lives of our patients. It would
have been unethical to have behaved in any other way. Thank you.
[The prepared statement of Dr. Fleischman follows:]
29
Statement of Alan Fleischman, M.D., Senior Advisor, New York Aeademy of
Medicine; Ethics Advisor, National Children’s Study at the National Insti-
tute of Child Health and Human Development; Clinical Professor of Pedi-
atrics and Clinical Professor of Epidemiology and Population Health, Al-
bert Einstein College of Medicine in New York
Mr. Chairman and Committee members, thank you for inviting me to share my
views with the Committee on the issue of Protection of Foster Children En-
rolled in Clinical Trials. My name is Alan Fleischman; I am a physician, pediatri-
cian and medical ethicist. I am Senior Advisor at The New York Academy of Medi-
cine and Ethics Advisor to the National Children’s Study at the National Institute
of Child Health and Human Development, as well as Clinical Professor of Pediatrics
and Clinical Professor of Epidemiology and Population Health at the Albert Einstein
College of Medicine in New York. I speak today as an individual, the opinions
I will express represent my own and do not represent the views or opinions
of any organization or institution with which I am or have been affiliated.
In the late 1980s and the early 1990s I was Professor of Pediatrics and Professor
of Epidemiology and Social Medicine at the Albert Einstein College of Medicine in
New York and served as Director of the Division of Neonatology at the Montefiore
Medical Center, that included responsibility for the newborn services at the vol-
untary hospital, Montefiore, and two public hospitals operated by the New York City
Health and Hospital Corporation, Jacobi Medical Center and North Central Bronx
Hospital. I was also a member of the two Institutional Review Boards for research
involving human subjects that was responsible for approval of all research involving
humans conducted at each of these hospitals.
I was a member of the American Academy of Pediatrics National Bioethics Com-
mittee from 1983-1989, and a member of the American Academy of Pediatrics AIDS
Committee from 1993-1999. In New York State, I was a member of the Department
of Health, AIDS Advisory Council Work Group on Ethical Issues in Access to Treat-
ment. In addition, I was asked, in 2001, by the Secretary of the U.S. Department
of Health and Human Services (DHHS) to serve as a member of the National
Human Research Protections Advisory Committee to the Office for Human Research
Protections and to chair the review of the federal regulations that govern research
involving children. I have also served as an expert advisor to the Institute of Medi-
cine’s Committee on Ethical Conduct of Clinical Research Involving Children.
I am currently a member of the New York State Governor’s Task Force on Life
and the Law, the New York City Mayor’s Commission on Women’s Issues, the
DHHS Secretary’s Advisory Committee on Human Research Protections’ Sub-
committee on Research Involving Children, and the Institute of Medicine Committee
on Ethical Issues in Housing-Related Health Hazard Research Involving Children
Youth, and Eamilies.
I am here today to express my strong belief that clinical research with therapeutic
intent involving children in foster care is an ethical imperative and can be per-
formed in an appropriate manner fully consistent with good ethical practice and
compliant with federal regulations that govern research.
In order to understand the issue of the enrollment of foster children in AIDS clin-
ical trials, you need to have a picture of AIDS care for children in the late 1980s
and the early 1990’s:
— 25% of babies born to women who were HIV infected developed HIV through
viral transmission in utero;
— AIDS was a universally fatal disease in children, with 25% of infected children
dying by 5 years old;
— many of the young children with HIV were “boarder-babies” who stayed in hos-
pitals or were placed in foster care because they had become orphans due to
the death of their mothers from AIDS, or because their mothers were too ill or
impaired to care for them;
— great strides were being made with new drugs developed for the treatment of
HIV and AIDS and its complications, but initial trials of these drugs included
only adults; multiple drug therapy was shown to save lives, and reverse some
of the major life-threatening illnesses associated with AIDS, but these new
treatments were not available to children;
— in fact, pediatric formulations of these drugs were not available to physicians
caring for young children with HIV and AIDS;
— the National Institutes of Health developed clinical research trials in order to
study the effectiveness of various new treatments in children; Some of the drugs
had the potential for side effects, but those possible risks were viewed by doc-
tors to be far out weighed by the potential therapeutic benefit of the new drugs
against AIDS, then a uniformly and often rapidly fatal disease.
30
A large percent of the children with HIV and AIDS in the late 1980s and the early
1990s in New York City and other parts of the country were poor, minority children,
and many of these children required foster care. It would have heen unconscionahle
and unjust, not to offer these children the very best prospect of life saving and life-
enhancing treatment. Enrollment in clinical trials was the only way to accomplish
that goal. If the agencies responsible for supervising the care of foster children in
the early 1990s refused to allow children to be enrolled in treatment trials, I and
many other clinicians would have demanded action in the interests of those chil-
dren.
In New York, the Administration for Children’s Services, the agency responsible
for supervision of foster children, developed mechanisms that made enrollment of
foster children in clinical trials possible. Local Institutional Review Boards for re-
search involving human subjects, like ours in the Bronx, approved the NIH treat-
ment trials for use in all children infected with HIV and helped investigators and
the Administration for Children’s Services to develop mechanisms to allow enroll-
ment of children in foster care.
The consent of biologic mothers was obtained when possible, agency permission
on an individual basis was obtained, and foster parents were involved in these dis-
cussions because of their need to administer treatments and bring children back for
followup visits to the hospital.
Let me also comment on the federal regulations that govern research involving
children with a specific emphasis on the section on “wards” in the regulations
(§45CFR46.409). I took the opportunity last week to clarify the regulations with a
senior member of the Office for Human Research Protections at the U.S. Depart-
ment of Health and Human Services and I believe that my views of the regulations
are consistent with his.
Clinical trials that include treatment with the prospect of direct benefit to the in-
dividual child are governed by section §45CFR46.405 of the federal regulations.
This section requires the permission of the parent or legal guardian in order to en-
roll any child in a study. It does not require the creation of an advocate for each
child that is a ward or in foster care. This approach is based on a clinical treatment
model. Only if the proposed research does NOT provide the prospect of direct benefit
for the individual child AND has a level of risk greater than minimal is the creation
of an advocate required by the regulations (§ 45CFR46.409).
Let me add that virtually all of the research projects involving foster children in
New York City were treatment trials with therapeutic intent. The individual institu-
tions conducting the trials had an Institutional Review Board that had to prospec-
tively approve the studies and may or may not have created special advocates or
processes for enrolling foster children. We did in the Bronx, but it was not man-
dated by the regulations. What was required was the permission of the biologic par-
ent or of the guardian, either the legal guardian or the agency fulfilling that respon-
sibility for the child.
Today, Pediatric AIDS treatment in the U.S. is different. Because of clinical trials
conducted in the 1990s, there are effective treatments to prevent children from be-
coming infected in utero and standard treatments for the small number of children
who are infected. AIDS in children has become a chronic disease with less than 1%
mortality each year for children treated in AIDS centers in the U.S. Children in fos-
ter care infected with HIV are getting standard treatment and are rarely partici-
pating in clinical trials because it is no longer a matter of life and death. But there
may be a time in the future, perhaps with the emergence of a new dreaded disease,
when we will once again be faced with the critical need to enroll foster children in
clinical trials in order to provide needed life saving treatments. The present federal
regulations allow us to do that, if we had to.
In conclusion, those of us involved in the treatment of children infected with HIV
in the late 1980s and 1990s knew that a large percentage of our patients were poor,
minority children and many of those children were in foster care. We demanded the
very best treatment for these vulnerable children. The only way to provide the best
treatment to any child with HIV at that time was through clinical trials — the drugs
were just not available any other way. We enrolled children in treatment trials and
gathered information on the effects of the new drugs on children, while we at-
tempted to save and enhance the lives of our patients. It would have been unethical
to have behaved in any other way; if we denied those new treatments to children
in foster care we would stand today open to severe criticism for having allowed our
most vulnerable children to have suffered or even die rather than offer them the
best chance of survival and the possibility of a good future quality of life. Thank
you.
31
Chairman MERGER. Thank you, Dr. Eleischman. Ms. Harris.
STATEMENT OF ROBERTA HARRIS, DEPUTY SECRETARY, WIS-
CONSIN DEPARTMENT OF HEALTH AND FAMILY SERVICES,
MADISON, WISCONSIN
Ms. HARRIS. Mr. Chairman, Members of the Subcommittee,
thank you for this opportunity to provide information to the Sub-
committee on this important topic. Children in the child welfare
system, whether in their own homes or in some form of out-of-home
care, are some of the most vulnerable children in our country. We
must do everything that we can to ensure that these children are
protected from any additional trauma. Clearly we need legitimate
medical and other research. Significant advances are made every
day as a result of well-designed and implemented research studies.
In Wisconsin, we have not approved medical research on foster
children or any subgroup of foster children as a class. In the child
welfare system, we believe it is our responsibility to provide as
much safe — as much of a safe and nurturing environment for the
children in foster care as possible.
Today I would like to make some comments related to the lack
of homogeneity of foster children, the problems with voluntary par-
ticipation on the part of families, and the legal framework of our
authority to consent to such research. Let me begin with lack of ho-
mogeneity. Research, whether medical or otherwise, should not be
limited to a particular group unless there is some homogeneity
within that group that is unique. In this regard, there is very little,
if anything, that can be regarded as homogeneous among children
in foster care other than that they have been removed from their
homes.
As many of us know, children in foster care are there for a vari-
ety of reasons; abuse or neglect of themselves or their siblings,
mental health issues of a severe nature, medical or developmental
disabilities with special care and treatment needs that cannot be
provided by their parents, and/or delinquency. Many of our chil-
dren are also from low-income families. As has been mentioned
here today, recent news articles have indicated that foster children
have participated in medical studies related to research endeavors
dealing with acquired immunodeficiency syndrome. It is true that
some children in foster care have HIV or AIDS. It is also true that
many children not in foster care have HIV or AIDS. To focus a
study on medication related to that condition only on children in
foster care where there are potential negative effects of those medi-
cations certainly leads to a perception that somehow foster children
are valued less than other children.
In Wisconsin, our position on the involvement of foster children
in research, especially medical research, is based in large part on
a variety of ethical codes related to medicine, social work, and men-
tal health. These codes place great emphasis on the voluntary na-
ture of participation research. We believe that our children and our
child welfare system are vulnerable, and it is our role to do what
we can to ensure the safety and welfare of the children in our sys-
tem. In addition, as I testified to earlier, many children in the child
welfare system are economically disadvantaged. We must recognize
this position and protect the family from giving consent under du-
32
ress. Voluntary consent goes to the heart of the nature of the rela-
tionships among children, their families, and the child welfare sys-
tem. “Voluntary” is defined as acting or performing without exter-
nal persuasion or compulsion.
Generally, out-of-home placements are ordered by the court.
When the agency that has authority to determine when a child be
returned to the parent recommends to that parent that the child’s
participation in medical research — recommends to that parent that
that parent approve the child’s participation in medical research,
at least on a perceived basis it is questionable whether the parent
would feel that his or her approval is truly voluntary.
This brings me to legal status. We need to look at the issue of
who can approve the involvement of a foster child in any type of
research, medical or otherwise. In the child welfare system, there
are generally four types of legal relationship between a child and
an individual agency acting on behalf of that child: physical cus-
tody, legal custody, guardianship and parental relationship. In
most cases in Wisconsin, the legal custody of a child in foster care
remains with the parent, because under Wisconsin statutes, there
shall be a policy of transferring custody of a child from the parent
only when there is no less drastic alternative.
If the parent’s rights have not been terminated, and if guardian-
ship has not been inferred on another party, then it is clear that
the parent should make the medical decisions for the child. As
noted previously, however, if the request for research participation
comes to the parent through the agency having the authority to de-
cide when the child is returned to the parent, one must legiti-
mately question whether the approval of the parent is given freely
and voluntarily. If a representative of the Wisconsin child welfare
system has court-appointed legal custody or guardianship and has
the authority to approve the participation of the foster child in
medical research, it is our position that the approval for such par-
ticipation should not be given solely on the basis of the child being
a foster child.
We are not opposed to the participation of a child — of a foster
child in appropriate and beneficial medical research on a case-by-
case basis if a foster children meets the requirements for a medical
research study based on some physical, mental, emotional or devel-
opmental condition; and the child’s parent or parents were in-
formed and, as is appropriate to their legal status, approved of
their child’s participation; and the child’s personal physician, thera-
pist and other qualified professional recommends to the system au-
thority the child be involved in that research; and children with
similar or related conditions will also participate; and the group of
children, and other individuals in the study, include children out-
side of the child welfare system; and finally, the child is appointed
an advocate with the express responsibility for determining wheth-
er participation is in the child’s best interest, including, if possible,
ascertaining the child’s position. If all of these are met, we would
consider granting that authority.
In summary, in Wisconsin, we believe it is our responsibility to
help provide a safe, nurturing environment for the children in our
foster care system so that they may become thriving, healthy
adults. We are opposed to a foster child being involved in any such
33
research solely because the child is a foster children. It is inappro-
priate to single out foster care children as a group for medical re-
search based simply on the fact that they are children in the child
welfare system. Thank you again for your invitation to address this
important issue. I trust that the legislative initiatives that will be
forwarded will reflect the values Wisconsin uses with regard to fos-
ter child protection in medical studies.
[The prepared statement of Ms. Harris follows:]
Statement of Roberta Harris, Deputy Secretary, Wisconsin Department of
Health and Family Services, Madison, Wisconsin
Thank you for this opportunity to provide information to the committee on this
very important topic. Children in the child welfare system, whether in their own
homes or in some form of out-of-home care, are some of the most vulnerable children
in our nation. It is critical that child welfare professionals, child advocates, medical
professionals, elected representatives, and the general public do all that we can to
ensure that these children are protected from any additional trauma.
It is not my intent to denigrate the important work reflected in most legitimate
medical and other research. Clearly, significant advances are made every day as a
result of well designed and implemented research studies.
In Wisconsin, we have not approved medical research on foster children as a class,
or any subgroup of foster children, because we believe it is our responsibility to pro-
vide as much of a safe, nurturing environment for the children in foster care as pos-
sible. The types of research that have unfortunately occurred in our nation in the
past would also make it difficult for us to earn the trust and confidence of the fami-
lies we are seeking to help, who desperately need the services we can offer.
As such, I would like to offer our comments on the topic related to the lack of
homogeneity of foster children, the problems with voluntary participation on the
part of families, and the legal realities of our authority to consent to such research.
1. Lack of Homogeneity
Research, whether medical or otherwise, should not be limited to a particular
group, unless there is some homogeneity within that group that is unique. In this
regard, there is very little — if anything — that can be regarded as homogenous
among children in foster care, other than that they have been removed from their
homes; in most cases, involuntarily.
Children in foster care are there for a variety of reasons: some have been
abused or neglected or had siblings who were abused or neglected; some have
mental health issues of a severe nature, sometimes as a result of the trauma of
being removed from their homes, parents, and siblings; some are medically frag-
ile or developmentally disabled with special care and treatment needs that can-
not be provided by their parents; some children are delinquent. Certainly, many
are from low income families.
Recent news articles have indicated that several states have allowed foster
children to participate in medical studies related to research endeavors dealing
with Acquired Immunodeficiency Syndrome (AIDS). It is certainly true that some
children in foster care have HIV or AIDS. It is also true that many children not
in foster care have HIV or AIDS. To focus a study, then, on medication related
to that condition only on children in foster care, when there are known potential
negative effects of those medications, certainly leads to a perception that some-
how foster children are valued less than other children.
2. Voluntary Nature of Participation
In Wisconsin, our position on the involvement of foster children in research, es-
pecially medical research, is based in large part on a variety of ethical codes re-
lated to medicine, social work, and mental health. A major document forming the
basis of our position is embodied in the The World Medical Association Declara-
tion of Helsinki, originally adopted in 1964, and as amended in 1975, 1983, 1989,
1996, 2000, 2002, and 2004, wbich places great emphasis on the voluntary nature
of participation in research.
Paragraph 1 of that document states, in part, that “. . . Some research popu-
lations are vulnerable and need special protection. The particular needs of the
economically and medically disadvantaged must be recognized. Special attention
is also required for those who cannot give or refuse consent for themselves, for
those who may be subject to giving consent under duress. . . .”
34
We believe the children in our child welfare system are vulnerable based upon
the trauma within their home, along with the distress that can be caused from
being removed from their family and placed into foster care. We believe it is our
role to do what we can to help ensure the safety and welfare of the children in
our system. In addition, as I testified to earlier, many children in the child wel-
fare system are economically disadvantaged. We must recognize their needs and
protect the family from giving consent under duress.
To continue from the World Medical Association Declaration of Helsinki, Para-
graph 20 states that “The subjects must be volunteers and informed participants
in the research project.”
Paragraph 23 states “When obtaining informed consent for the research project
the physician should be particularly cautious if the subject is in a dependent rela-
tionship with the physician or may consent under duress. In that case the in-
formed consent should be obtained by a well-informed physician who is not en-
gaged in the investigation and who is completely independent of this relation-
ship.”
Paragraph 24 states that “For a research subject who is legally incompetent,
physically or mentally incapable of giving consent or is a legally incompetent
minor, the investigator must obtain informed consent from the legally authorized
representative in accordance with applicable law. These groups should not be in-
cluded in research unless the research is necessary to promote the health of the
population represented and this research cannot instead be performed on legally
competent persons.”
Paragraph 25 states that “When a subject deemed legally incompetent, such as
a minor child, is able to give assent to decisions about participation in research,
the investigator must obtain that assent in addition to the consent of the legally
authorized representative.”
I raise these issues related to consent because, to a certain extent, they go to
the heart of the nature of the relationships among children, their families, and
the child welfare system. In the context noted above, two definitions of the term
“voluntary” should be carefully considered:
Voluntary: Done, given, or proceeding from the free or unconstrained will of a
person. [The World Book Dictionary]
Voluntary: Acting or performed without external persuasion or compulsion.
[The American Heritage Dictionary of the English Language]
With the exception of some of the small percent of voluntary placements, out-
of-home placements are ordered by the court. As such, when the agency that has
the authority to determine when a child will be returned to the parent rec-
ommends that the parent approve the child’s participation in medical research,
at least on a perceived basis, it is questionable whether the parent would feel
that his or her approval is truly voluntary.
3. Legal Status
This brings us to the issue of who can approve the involvement of a foster child
in any type of research, medical or otherwise. In the child welfare system, there
are generally four types of legal relationship between a child and an individual
or agency acting on that child’s behalf These are physical custody, legal custody,
guardianship, and the parental relationship, which are defined as the following:
Physical custody means actual custody of the person in the absence of a court
order granting legal custody to the physical custodian, [s. 48.02(14)] In the con-
text of this hearing, the foster parent would be a physical custodian only, because
in Wisconsin, they would not generally have legal custody.
Legal custody is a status created by the order of a court, which confers the
right and duty to protect, train and discipline the child, and to provide food, shel-
ter, legal services, education and ordinary medical and dental care, subject to the
rights, duties and responsibilities of the guardian of the child and subject to any
residual parental rights and responsibilities and the provisions of any court
order, [s. 48.02(12)] In most cases in Wisconsin, the legal custody of a child in
foster care will remain with the parent because, under our statutes, “. . . there
shall be a policy of transferring custody of a child from the parent . . . only when
there is no less drastic alternative, if there is no less drastic alternative for a
child than transferring custody from the parent, the judge shall consider trans-
ferring custody to a relative whenever possible.” [s. 48.355(1)]
We believe that maintaining the parents’ involvement, responsibility, and au-
thority when a child is placed outside of the home is critical, if the goal is to re-
unify the child with the family.
35
Guardianship means a status granted by the court to a person who has the
duty and authority to make important decisions in matters having a permanent
effect on the life and development of the child and the duty to be concerned about
the child’s general welfare, including but not limited to:
• The authority to consent to marriage, enlistment in the U.S. armed forces,
major medical, psychiatric and surgical treatment, and obtaining a motor ve-
hicle operator’s license.
• The authority to represent the child in legal actions and make other deci-
sions of substantial legal significance concerning the child but not the au-
thority to deny the child the assistance of counsel as required by this chap-
ter.
• The right and duty of reasonable visitation of the child.
• The rights and responsibilities of legal custody except when legal custody has
been vested in another person or when the child is under the supervision of
the department of corrections ... or the supervision of a county department
. . . [s. 48.023]
The parental relationship, of course, is one in which the parent has all of the
rights and responsibilities related to the care of his or her child which have not
been otherwise altered by the action of a court.
Parental Authority for Participation. If parental rights have not been termi-
nated, and if guardianship has not been inferred on another party, the parents
retain the right to make medical decisions for the child.
System Authorization for Participation. Occasionally, a representative of the
Wisconsin child welfare system is granted court-appointed legal custodianship or
guardianship and would have the ability to approve the participation of a foster
child in medical research. In these instances, it is our position that approval for
such research participation should not be given solely on the basis of the child
being a foster child, but rather reviewed on a case-by-case basis for medical bene-
fits.
In other words, we are not opposed to the participation of a foster child in ap-
propriate and beneficial medical research if:
• a foster child meets the requirements for a medical research study based on
some physical, mental, emotional, or developmental condition and
• the child’s parent or parents were informed and, as appropriate to their legal
status, approved of their child’s participation and
• the child’s personal physician, therapist, or other professional recommends to
the system authority that the child be involved in that research and
• children with similar or related conditions will also participate and
• the group of children and other individuals in the study include children out-
side of the child welfare system and
• the child was appointed an advocate with the express responsibility for deter-
mining whether participation is in the child’s best interest (including
ascertaining the child’s position),
the representative may consider granting that authority. In Wisconsin, we be-
lieve it is our responsibility to help provide a safe, nurturing environment for the
children in foster care so that they may become healthy, thriving adults. We are
opposed to a foster child being involved in any such research solely because the
child is a foster child. It is inappropriate to single out foster care children as a
group for medical research, based simply on the fact that they are in the child
welfare system.
Thank you again for your invitation to address this important issue. I wish you
well and trust that legislative initiatives will be forwarded that reflect the values
Wisconsin uses with regard to foster child participation in medical studies.
Chairman MERGER. Thank you, Ms. Harris. Dr. Speers to tes-
tify.
36
STATEMENT OF MABJORIE SPEERS, Ph.D., EXECUTIVE DIREC-
TOR, ASSOCIATION FOR THE ACCREDITATION OF HUMAN
RESEARCH PROTECTION PROGRAMS, INC.
Ms. SPEERS. Good afternoon, and thank you for inviting me to
speak about the roles of IRBs and protections for children when
they are research subjects. IRBs have a broad responsibility to
safeguard the rights and welfare of research subjects. Thus, they
should be sufficiently qualified to review the research that comes
before them and to ascertain the acceptability of proposed studies
in terms of institutional commitments and requirements, applicable
law and standards of professional practice. IRBs and institutions
that receive funds from the Department of Health and Human
Services or review research that the Food and Drug Administration
regulates must abide by Federal regulations to protect research
subjects and Subpart D, which provides additional protections for
children participating in research. As stipulated in the regulations,
IRBs must have at least five members with varying backgrounds
to promote complete and adequate review of research. At least one
member must have primary concerns in the scientific area, at least
one member must have primary concerns in nonscientific areas,
and at least one member must not be otherwise affiliated with the
institution.
The primary role of the IRB is to determine whether a proposed
study is ethically justifiable. The Federal regulations lay out seven
criteria for IRB approval of research. They include risks to subjects
are minimized; risks to subjects are reasonable in relation to poten-
tial benefits, including direct benefits to subjects and the impor-
tance of the knowledge that might be gained; subjects are selected
equitably; informed consent is sought from each prospective subject
or legally authorized representative and documented; and when ap-
propriate, the research plan includes monitoring the data to ensure
the safety of subjects and includes provisions to protect the privacy
of subjects and to maintain the confidentiality of the data. IRBs
use written procedures, checklists and other tools to assist them in
complying with the regulations. During IRB meetings, an IRB
member usually describes the proposed study, and all members dis-
cuss and debate the ethical and scientific issues relating to the pro-
tection of prospective subjects. In the end, they come to a conclu-
sion to approve or disapprove the study, request more information,
or require modifications of the study in order to approve it.
Involving children in research poses special ethical dilemmas.
Aside from State laws governing the age of majority and who may
consent on behalf of the child to participate in research, children,
by nature of their developing cognitive abilities, are unable to give
voluntary informed consent to participate in a study. IRBs consider
this carefully in research involving children. IRBs must make spe-
cific determinations regarding the level of risk involved in a pro-
posed study and whether there is a prospect of direct benefit to the
individual subject. They may approve research only when it falls
into one of four permitted categories. Research involving greater
than minimal risk can only be approved when it meets certain reg-
ulatory criteria. These determinations are not easy to make be-
cause IRBs must interpret regulatory terms such as “minimal risk”
or “minor increase over minimal risk.”
37
One of the main protections for children is the requirement that
IRB approve research in which investigators solicit assent from the
child and permission from the parents or guardians, individuals
who are authorized under law to consent on behalf of a child.
Under the regulations, IRBs may approve research involving chil-
dren who are wards. Depending on the level of risk and whether
there is a possibility of direct benefit to the child-subject, a child
advocate might be required. For example, in order to approve a
study involving greater than minimal risk and no prospect of direct
benefit to the individual subjects, IRBs must find that the research
is related to their status as wards or is conducted in settings such
as schools where the majority of children involved as subjects are
not wards. Further, IRBs must require the appointment of an advo-
cate for each child who is a ward, in addition to anyone who is act-
ing on behalf of the child as a guardian.
In summary, there are a number of regulatory requirements to
ensure that children participating in research are adequately pro-
tected. When IRBs and investigators implement these additional
protections, the system works well. Thank you for the opportunity
to address the Subcommittee.
[The prepared statement of Dr. Speers follows:]
Statement of Marjorie Speers, Ph.D., Executive Director, Association for
the Accreditation of Human Research Protection Programs, Inc.
Good afternoon. My name is Marjorie Speers. I am the Executive Director of the
Association for the Accreditation of Human Research Protection Programs — an orga-
nization that accredits institutional review boards, or IRBs, as part of a broader
human research protection program. I was invited to speak about the roles of IRBs
and protections for children when they are research subjects.
IRBs have a broad responsibility to safeguard the rights and welfare of research
subjects. Thus, they should be sufficiently qualified to review the research that
comes before them and to ascertain the acceptability of proposed studies in terms
of institutional commitments and requirements, applicable law, and standards of
professional practice.
IRBs in institutions that receive funds from the Department of Health and
Human Services or review research that the Food and Drug Administration regu-
lates must abide by federal regulations to protect research subjects and Subpart D,
which provides additional protections for children participating in research.
As stipulated in the regulations, IRBs must have “at least five members with
varying backgrounds to promote complete and adequate review of research,” at least
one member must have primary concerns in the scientific area, at least one member
must have primary concerns in nonscientific areas, and at least one member must
not be otherwise affiliated with the institution.
The primary role of the IRB is to determine whether a proposed study is ethically
justifiable. The federal regulations lay out seven criteria for IRB approval of re-
search. Briefly, they include: risks to subjects are minimized; risks to subjects are
reasonable in relation to potential benefits, including direct benefits to subjects and
the importance of the knowledge that might be gained; subjects are selected equi-
tably; informed consent is sought from each prospective subject or legally authorized
representative and documented; and when appropriate, the research plan includes
monitoring the data to ensure the safety of subjects and includes provisions to pro-
tect the privacy of subjects and to maintain the confidentiality of the data.
IRBs use written procedures, checklists, and other tools to assist them in com-
plying with the regulations. During IRB meetings, an IRB member usually describes
the proposed study and all discuss and debate the ethical and scientific issues relat-
ing to the protection of prospective subjects. In the end, they come to a conclusion
to approve or disapprove the study, request more information, or require modifica-
tions of the study in order to approve it.
Involving children in research poses special ethical dilemmas. Aside from state
laws governing the age of majority and who may consent on behalf of the child to
participate in research, children by nature of their developing cognitive abilities are
38
unable to give voluntary informed consent to participate in a study. IRBs consider
very carefully research involving children.
IRBs must make specific determinations regarding the level of risk involved in a
proposed study and whether there is a prospect of direct benefit to the individual
subjects. They may approve research only when it falls into one of four permitted
categories. Research involving greater than minimal risk can only be approved when
it meets certain regulatory criteria. These determinations are not easy to make be-
cause IRBs must interpret regulatory terms, such as “minimal risk” or “minor in-
crease over minimal risk.”
One of the main protections for children is the requirement that IRBs approve re-
search in which investigators solicit assent from the child and permission from the
parents or guardians — individuals who are authorized under law to consent on be-
half of a child. Under the regulations, IRBs may approve research involving children
who are wards. Depending on the level of risk and whether there is a possibility
of direct benefit to the child-subject, a child advocate might be required. For exam-
ple, in order to approve a study involving greater than minimal risk and no prospect
of direct benefit to individual subjects, IRBs must find that the research is related
to their status as wards or is conducted in settings, such as schools, where the ma-
jority of children involved as subjects are not wards. Further, IRBs must require
the appointment of an advocate for each child who is a ward, in addition to anyone
who is acting on behalf of the child as a guardian.
In summary, there are a number of regulatory requirements to ensure that chil-
dren participating in research are adequately protected. When IRBs and investiga-
tors implement these additional protections, the system works well. Thank you for
the opportunity to address the Subcommittee.
Chairman HERGER. Thank you, Dr. Speers. Dr. Szilagyi to tes-
tify.
STATEMENT OF MOIRA SZILAGYI, M.D., Ph.D., FELLOW OF THE
AMERICAN ACADEMY OF PEDIATRICS, ON BEHALF OF THE
AMERICAN ACADEMY OF PEDIATRICS
Dr. SZILAGYI. Mr. Chairman, I am grateful for the opportunity
to testify as this important hearing on children in foster care and
clinical trials. My name is Dr. Moira Ann Szilagyi, and I am proud
to speak on hehalf of 60,000 primary care pediatricians, pediatric
medical subspecialists and pediatric surgical specialists of the
American Academy of Pediatrics. For the past 19 years, I have spe-
cialized in the medical care and developmental issues of children
in foster care. I am an associate professor of pediatrics at the Uni-
versity of Rochester Medical Center in Rochester, New York; a
medical director of Monroe County Department of Health’s Foster
Care Pediatrics Clinic. I also serve on the American Academy of
Pediatrics Committee on Early Childhood, Adoption and Dependent
Care. The academy has a deep and abiding interest in the health
care provided to children in the child welfare system. In fact, the
academy has numerous published policy statements, clinical guide-
lines and studies regarding children in foster care, including this,
a 170-page handbook for pediatricians on health care standards for
children in foster care. I was proud to chair the District II Task
Force on Health Care for Children in Foster Care, which authored
this resource manual.
The 540,000 children in foster care comprise one of many vulner-
able populations to which the academy urges special attention in
the provision of health care. Compared with children from the
same socioeconomic background, children in foster care have much
higher rates of serious emotional and behavioral problems, chronic
physical disabilities, birth defects, developmental delays, and poor
39
school achievement. Typically these conditions are chronic, under-
identified, and undertreated, and they have an ongoing impact on
all aspects of their lives, even long after these children and adoles-
cents have left the foster care system. As a result, children in fos-
ter care warrant special attention in all aspects of their health
care. One aspect in which children in foster care deserve particu-
larly close and special consideration is their inclusion in clinical
trials. It is the position of the American Academy of Pediatrics that
drugs he studied in children to determine their safety and efficacy
in this age group. Indeed, the academy considers it a moral impera-
tive to formally study drugs in children so that they can enjoy
equal access to existing as well as new therapeutic agents.
Research participation is often beneficial to participants and may
allow them access to care they could not otherwise receive. There-
fore, children in foster care, as a population that tends to have a
greater preponderance of special health care needs, should he af-
forded the same opportunities and access to safe and effective
treatments. However, special consideration is necessary when al-
lowing children in foster care who are in the care and custody of
the State to take part in certain studies that may contain greater
than minimal risk to the child.
The academy has developed extensive guidelines and standards
related to the ethical conduct of clinical trials involving children.
The academy also agrees with the Department of Health and
Human Services’ regulations governing the inclusion of children in
clinical research. For the purposes of today’s hearings, however,
perhaps the most relevant standards deal with consent. Young chil-
dren are, hy definition, incapable of consenting to medical proce-
dures. Consent must be given on their behalf by a parent, a legal
guardian or an individual or institution acting in loco parentis; that
is, in place the of the parent. In all cases, however, the overriding
consideration must be the best interest of the child.
HHS regulations outline issues of consent. Consent must be ob-
tained from the adult acting legally on behalf of the child. When
developmentally appropriate, the assent of the child must be
gained prior to participation in any clinical trial. The question,
then, for children in foster care is whether adequate safeguards are
established when consent is obtained for trials that contain above
minimal risk to the child or when the research does not hold the
prospect of providing direct medical benefit to the child him or her-
self
For children in the foster care system, an important safeguard is
a special advocate who can help the foster family or State agency
navigate medical issues, ensure that the child’s medical care needs
are being met, assist the child in determining whether or not he
or she should participate, and provide a source of continuity for the
child and the legal guardians throughout the duration of the study.
Even in cases of less than minimal risk or studies with prospect
of direct benefit, an advocate, while not required, could play an im-
portant role in the child’s support system. It is my understanding
that the Subcommittee is concerned by press reports about the par-
ticipation of children in foster care in clinical trials of HIV drug
treatments that began in the late eighties. My own professional ex-
perience includes a number of cases of HIV-positive children in fos-
40
ter care in my community who received HIV multidrug treatments
during the early nineties. When our patients took these drug com-
binations, we saw a startling improvement in lifespan and quality
of life. Before the introduction of these combination drugs, our
HIV-positive children in care were literally wasting away before
our eyes.
There were some side effects with the drugs, but not that many,
and the side effects were nothing compared to the devastation of
the disease. I recall one 2-year-old child in particular who was lit-
erally dying. One year after receiving combination therapy, he was
essentially indistinguishable from his healthy peers. He was able
to go to preschool, live in a family instead of the hospital, and have
hope for a longer life. He is still alive today and was eventually
adopted by his foster family. Mr. Chairman, the decision to enroll
a child in a clinical trial is never an easy one, even in a traditional
family structure. While the headlines seem to suggest that children
in foster care were somehow singled out as hapless guinea pigs, my
experience indicates that children in foster care are actually less
likely than other children to be considered for participation in a
clinical trial. In fact, numerous barriers exist for children in foster
care to even obtain routine health care and necessary health serv-
ices. Participation in a clinical trial where access would be far more
complex is even less likely to occur.
The American Academy of Pediatrics believes that children in
foster care deserve to be offered the same opportunities as other
children to benefit from newer drugs and treatment protocols, espe-
cially when a child’s condition is so grave that there are few op-
tions available to them. Indeed, it would be unethical to do other-
wise and systematically deny access to clinical trials that could
have saved their lives or vastly improved the health of critically ill
children in foster care. It is clear that children in foster care are
a special population, and that they deserve additional protections
when being considered for inclusion in clinical trials.
Mr. Chairman, and Members of the Subcommittee, I deeply ap-
preciate this opportunity to offer testimony on behalf of the Amer-
ican Academy of Pediatrics. A more detailed version of my testi-
mony has been submitted for the record. I stand ready to answer
any questions you may have, and I thank you for your commitment
to the health of the children of our Nation.
[The prepared statement of Dr. Szilagyi follows:]
Statement of Moira Ann Szilagyi, M.D., Ph.D., Associate Professor of Pediat-
rics at the University of Rochester Medical Center, Rochester, New York;
Medical Director, Foster Care Pediatrics Clinic, Monroe County Depart-
ment of Health; and Member, Committee on Early Childhood, Adoption
and Dependent Care, American Academy of Pediatrics
Mr. Chairman, I am grateful for the opportunity to testify at this important hear-
ing on children in foster care and clinical trials. My name is Dr. Moira Ann Szilagyi,
and I am proud to speak on behalf of the 60,000 primary care pediatricians, pedi-
atric medical subspecialists, and pediatric surgical specialists of the American Acad-
emy of Pediatrics. For the past 19 years, I have specialized in medical care and de-
velopmental issues of children in foster care. I am an associate professor of pediat-
rics at the University of Rochester Medical Center in Rochester, New York and Med-
ical Director of the Monroe County Department of Health’s Foster Care Pediatrics
clinic. I also serve on the American Academy of Pediatrics’ Committee on Early
Childhood, Adoption and Dependent Care.
41
The Academy has a deep and abiding interest in the health care provided to chil-
dren in the child welfare system. In fact, the Academy has published numerous pol-
icy statements, clinical guidelines, and studies regarding children in foster care, in-
cluding a 170-page handbook for pediatricians on health care standards for children
in foster care. I was proud to chair the District II Task Force on Health Care for
Children in Foster Care, which authored that resource manual.
The 540,000 children in foster care comprise one of many vulnerable populations
to which the Academy urges special attention in the provision of health care. Com-
pared with children from the same socioeconomic background, children in foster care
have much higher rates of serious emotional and behavioral problems, chronic phys-
ical disabilities, birth defects, developmental delays, and poor school achievement.^
Typically, these conditions are chronic, under-identified, and under treated, and
they have an ongoing impact on all aspects of their lives, even long after these chil-
dren and adolescents have left the foster care system.^ As a result, children in foster
care warrant special attention in all aspects of their health care.
One aspect in which children in foster care deserve particularly close and special
consideration is their inclusion in clinical trials. It is the position of the American
Academy of Pediatrics that drugs must be studied in children to determine their
safety and efficacy in this age group. Indeed, the Academy considers it a moral im-
perative to formally study drugs in children so that they can enjoy equal access to
existing, as well as new, therapeutic agents.^ Research participation is often bene-
ficial to the participants, and may allow them access to care they could not other-
wise receive. Therefore, children in foster care, as a population that tends to have
a greater preponderance of special health care needs, should be afforded the same
opportunities and access to safe and effective treatments. However, special consider-
ation is necessary when allowing children in foster care who are in the care and
custody of the state to take part in certain studies that may contain greater than
minimal risk to the child.
The Academy has developed extensive guidelines and standards related to the
ethical conduct of clinical trials involving children. The Academy also agrees with
the Department of Health and Human Services’ (HHS) regulations governing the in-
clusion of children in clinical research (CFR 45 Part 46, Subpart D). For the pur-
poses of today’s hearing, however, perhaps the most relevant standards deal with
consent. Young children are, by definition, incapable of consenting to medical proce-
dures. Consent must be given on their behalf by a parent, a legal guardian, or an
individual or institution acting in loco parentis — that is, in the place of the parent.
The Academy’s foster care handbook. Fostering Health, dedicates an entire chap-
ter to medical consents for children and adolescents in foster care."* States and local-
ities have varying laws and detailed policies related to the ability of individuals in-
volved in a child’s care to consent to medical care or procedures. Many localities
have convened multidisciplinary teams to determine what is in a child’s best inter-
est when confronted with complex health issues for children in their care. In gen-
eral, legal guardianship remains with the birth parents (a term which includes legal
guardians) unless a child is freed for adoption. There have certainly been cases
when children who are in foster care are enrolled in clinical trials with the full con-
sent of their birth parents. In certain cases when the birth parents are unavailable
or uncooperative, agencies may approve or seek a court order for medical proce-
dures — such as participation in clinical trials — for which written consent is required
and which are deemed to be in the best interests of the child. Once a child is freed
for adoption, the state agency assumes sole responsibility for consenting for a child’s
medical care.® In all cases, however, the overriding consideration must be the best
interest of the child.
HHS regulations outline issues of consent: consent must be obtained from the
adult acting legally on behalf of the child, and, when developmentally appropriate,
the assent of the child must be gained prior to participation in any clinical trial.
The question, then, for children in foster care is whether adequate safeguards are
established when consent is obtained for trials that contain above minimal risk to
the child, or when the research does not hold the prospect of providing direct med-
1 Committee on Early Childhood, Adoption and Dependent Care. “Health Care of Young Chil-
dren in Foster Care.” Pediatrics, Vol. 109, No. 3, March 2002.
2 Task Force on Health Care for Children in Foster Care. Fostering Health: Health Care for
Children in Foster Care. 2nd ed. American Academy of Pediatrics, 2005.
3 Committee on Drugs. “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in
Pediatric Populations.” Pediatrics, Vol. 95, No. 2, February 1995.
^Committee on Drugs. “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in
Pediatric Populations.” Pediatrics, Vol. 95, No. 2, February 1995.
®Task Force on Health Care for Children in Foster Care. Fostering Health: Health Care for
Children in Foster Care. 2nd ed. American Academy of Pediatrics, 2005.
42
ical benefit to the child him or herself. For children in the foster care system, an
important safeguard is a special advocate who can help the foster family or state
agency navigate medical issues, ensure that the child’s medical care needs are being
met, assist the child in determining whether or not he or she should participate,
and provide a source of continuity for the child and legal guardians throughout the
duration of the study (section 46.409). Even in cases of less than minimal risk or
studies with prospect of direct benefit, an advocate, while not required, could play
an important role in the child’s support system.
HHS regulations state — and the Academy concurs — that children in foster care
should not be considered for studies which contain the prospect of greater than
minimal risk and in which there is no direct benefit to the child him or herself
(46.406-407). For these studies, it is only appropriate to consider using children in
foster care under certain circumstances, such as if the research is related to their
status as wards of the state. In other words, they should only be included when in-
volvement of children in foster care is necessary since the research aims to answer
a question related to conditions specifically affecting children in foster care. In these
rare instances, it is imperative that an advocate be appointed to act on behalf of
the child for the duration of the study to assist the child and foster family for the
reasons stated above: to navigate medical issues, ensure that the child’s medical
care needs are being met, assist the child in determining whether to participate,
and provide a source of continuity for the child and legal guardians throughout the
duration of the study.
It is my understanding that the subcommittee is concerned by recent press re-
ports about the participation of children in foster care in clinical trials of HIV drug
treatments that began in the late 1980s. While attention has been paid specifically
to these HIV drug trials, children in foster care have been known to participate in
other types of clinical trials, including those focused on cancer treatment. My own
professional experience includes a number of cases of HIV-positive children in foster
care in my community who received HIV multi-drug treatments during late 1980s
and early 1990s. When our patients took these drug combinations, we saw a star-
tling improvement in lifespan and quality of life. Before the introduction of these
combination drugs, our HIV-positive foster children were literally wasting away be-
fore our eyes. There were some side effects with the drugs, but not that many. I
recall one two-year-old child in particular who was literally dying. One year after
receiving combination therapy, he was essentially undistinguishable from his
healthy peers. He was able to go to preschool, live in a family instead of the hos-
pital, and have hope for a longer life. He is still alive today and was adopted by
his foster family.
Mr. Chairman, the decision to enroll a child in a clinical trial is never an easy
one, even in a “traditional” family structure. While the headlines seem to suggest
that children in foster care were somehow singled out as hapless guinea pigs, my
experience indicates that children in foster care are actually less likely than other
children to be considered for participation in a clinical trial. In fact, numerous bar-
riers exist for children in foster care even to obtain routine health care and nec-
essary services. Participation in a clinical trial, where care would be far more com-
plex, is even less likely to occur.
The American Academy of Pediatrics believes that children in foster care deserve
to be offered the same opportunities as other children to benefit from newer drugs
and treatment protocols, especially when a child’s condition is so grave that there
are few options available to them. Indeed, it would be unethical to do otherwise and
systematically deny access to clinical trials that could have saved the lives or vastly
improved the health of critically ill children in foster care. It is clear that children
in foster care are a special population, and that they deserve additional protections
when being considered for inclusion in clinical trials.
Mr. Chairman and Members of the Subcommittee, I deeply appreciate this oppor-
tunity to offer testimony on behalf of the American Academy of Pediatrics. I stand
ready to answer any questions you may have, and I thank you for your commitment
to the health of the children of our nation.
Chairman HERGER. Thank you, Dr. Szilagyi. The gentleman
from Colorado Mr. Beauprez to inquire.
Mr. BEAUPREZ. Thank you, Mr. Chairman. Doctor, let’s just
start with you, if I might. I am intrigued by your testimony and
especially, I think, your closing assertion that the very children
43
that may need the opportunity to participate in these trials, may
need good health care in general, are ones that, perhaps, are being
denied, foster children. I am concerned that perhaps in our zeal to
do something, we maybe do too much. Congress sometimes can do
that. If you can enlighten me a little bit, what maybe should we
be doing; and even more specifically, since we’re focused on HIV/
AIDS, and that seems to be a situation that occurred quite a few
years ago, tell me from what you know, and you would appear to
be a pretty good expert at this, what sort of clinical trials are going
on today? We’re talking a lot of about what went on 10 or 15 years
ago. What is going on today, and what, in your opinion, should
Congress do?
Dr. SZILAGYI. Are you asking me about specifically what clin-
ical drug trials or what types of trials?
Mr. BEAUPREZ. What type of trials?
Dr. SZILAGYI. I think most of the research that is centered on
children in foster care from the health perspective now has to do
with mental health interventions for children, and possibly devel-
opmental interventions for children; visitation, mentored visitation
interventions. I put those in health because I look at health as a
very global issue for children in foster care. There are still occa-
sionally children who might be enrolled in a drug trial, but those
are usually children with rare illnesses, childhood cancers that
haven’t responded to more traditional therapies, and that they be
offered the same opportunity as any other child to become involved
in a therapeutic drug trial, that may be their own only last best
option for life. That is an extremely rare event. It has happened —
I have taken care of probably close to 9,000 children in foster care
over the last 19 years of my practice, and, you know, that num-
ber — those faces change all the time because of the nature of my
practice. I have really only had occasion to have that situation out-
side of the HIV situation come up probably two other times. So, it
is not — ^you know, we don’t have vast numbers of children involved
in these randomized controlled clinical trials.
Mr. BEAUPREZ. Ms. Harris, near the end of your testimony, I
think it is on page 4 of your written testimony, you outlined, I be-
lieve, six different criteria for a child — a foster care child to be in-
cluded in a clinical trial. Are any of those — do all of those have to
be met in the affirmative in order for a child to be included?
Ms. HARRIS. Yes, as stated.
Mr. BEAUPREZ. Which raises, actually, another question, and I
fully understand and appreciate how we could get to that point.
Another concern I actually had raised to me about the very point
you’re talking about, about making these kind of opportunities
available, not precluding foster children from the population, is
that perhaps in our concern about making sure the wrong thing
doesn’t happen to the wrong child for the wrong reasons, that by
an abundance of regulations and hoops to jump through we actu-
ally do just that; that it is not a very attractive target — a very at-
tractive population, excuse me — a very attractive population to
even look at for clinical trials because of the regulation burden we
put in front of them.
44
Ms. HARRIS. Well, my guess is that most of these criteria, with
the exception of appointing an advocate, would he applicable to all
children that are going to be involved in medical trials.
Mr. BEAUPREZ. So, in my case, if it were one of my children,
it would be another advocate. Would there — since I am the parent,
the biological parent, I have legal custody, we wouldn’t be setting
up another hurdle, would we?
Ms. HARRIS. No, not with respect to the advocate.
Mr. BEAUPREZ. I am not suggesting the advocate go away. Ac-
tually, Dr. Eleischman, I wanted to pursue that a little bit with
you. What exactly did you do in the Bronx? I want to be sure and
ask, I think, two related questions: Why is this — if most of this
occurred — most of what we read in the press occurred 10, 15 years
ago, why are we just now kind of hearing about it? It is being
brought to light, and I think HHS regulations neither preclude now
nor mandate certainly that there be any payment made, but are
you familiar with payments ever being made; and, if so, who gets
paid for these clinical trials?
Dr. ELEISCHMAN. The why now question, I think you’re going
to have to ask people other than myself I have no idea why now.
I find no rational reason for what I thought was a rewriting of his-
tory in much of the media circus. In terms of the question of why,
what we did in the Bronx, we did appoint a physician advocate who
was in one of our public hospitals to share his views on these trials
with each of the foster families, and we did use his expertise to
help the foster families, help decide whether the child ought to be
in the trial after the other steps had been gone through of individ-
ualized consent from the agency, legal guardian or parent, review.
This was an adjunct, an added thing, that we at the Albert Ein-
stein College of Medicine felt was important. In terms of the pay-
ment, families who enroll children in clinical trials generally do re-
ceive some compensation for their efforts in bringing the child to
the clinic; transportation, time away from work, things of that sort.
To my knowledge, there were no dollars in true payment for using
children or commodifying children in such clinical trials, and most
IRBs would not tolerate such.
Mr. BEAUPREZ. Good.
Chairman HERGER. The gentleman’s time has expired.
Mr. BEAUPREZ. Thank you, Mr. Chairman.
Chairman HERGER. The gentleman from Washington Mr.
McDermott to inquire.
Mr. MCDERMOTT. Thank you, Mr. Chairman. As I listen to this
panel, I come away with a question. I ^ess it sounds like in Wis-
consin you wouldn’t get into a clinical trial like this; is that correct?
Ms. HARRIS. With foster care children as a class. We are not
saying that we don’t think foster care children should be eligible
for clinical trials. If they are eligible, they should be treated as any
other child and have parental consent or consent of the legal au-
thority that has legal custody of the child.
Mr. MCDERMOTT. I asked my staff after I listened to all of you,
why are we here? Not exactly Mr. Beauprez’s question. I read these
articles from the Newsday and from the New York papers that cov-
ered this issue. I tend to agree with Dr. Eleischman. There seems
to be a — this was a long time ago, and a whole different scene.
45
What I would really like to hear from you, you all are advocates
for children, all of you. Is there anything that we should do to
make a uniform system across the country so that there is no real
magical difference? This whole question about should we override
what goes on at the State level, is that a good idea in this area?
Or do you see something where there is a Federal role that we
should do? None of you made any recommendations. I don’t know
whether that was because you didn’t have any or didn’t think there
should be any changes, or it was all perfect out there. So, Dr.
Fleischman?
Dr. FLEISCHMAN. I, individually, myself, had three opportuni-
ties through service to the government to review the regulations for
children, and in each of those times, we felt those regulations were
adequate. The National Bioethics Advisory Commission, Dr.
Shalala, Secretary Shalala’s Human Research Protections Advisory
Committee, and the now Secretary’s Advisory Committee have all
suggested, as well as the lOM Institute’s reports, the Institute of
Medicine reports, all suggested that we would benefit in this coun-
try, not specifically in the foster care, only in foster care, in a basic
data collection system that would assist us in understanding who
are the subjects of research in our country, what are the criteria
that IRBs are using in approving research, and what are the out-
comes based in those research studies. The Office of Human Re-
search Protection has not requested that. They feel, I believe, that
they don’t have the authority to do that. I don’t speak for them, but
we would be well served by having a database that at least gives
us the baseline information about such. That is one. Two, all of
those groups have recommended that there be expertise in pediat-
rics — you can call it advocates or experts in pediatrics — on any IRB
that is reviewing things related to children. It isn’t required in the
regulations. It could be strongly urged, or it could be required. All
of those learned groups have made those recommendations, and I
believe for the most part IRBs fulfill those recommendations. In
these cases, since these were — these research prospects were in
AIDS clinical trials centers, centers of excellence in our cities, all
of those IRBs had advocates for children and had children’s experts
on them. In general, if we are looking to fix, or help, or support
the present regulatory structure of the data collection system and
expertise in the areas related to the kinds of subjects who are
being reviewed like prisoners, or children, or mentally ill people, or
retarded people, or people of any variety
Mr. MCDERMOTT. Any of the others of you have a comment?
Dr. SZILAGYI. I probably have a broader perspective on the
whole issue of health care for children in foster care than the more
narrowly defined. I agree with everything Dr. Eleischman said. Let
me start there. I think that children in foster care have huge
health care needs. Eorty-five percent of them have chronic medical
illness. Sixty percent of children under the age of 5 have develop-
mental disabilities. Eorty-five percent of our school-age children are
in special education placements, and eighty percent of children over
the age of 4 have mental health needs. Their access to health care
services is abysmal in this country. There are multiple barriers.
One of you asked about barriers before. Those barriers include
their high mobility in and out of the system; the high mobility of
46
professionals in the system; Medicaid as a funding resource, which,
while it offers some benefits in terms of routine preventive care, is
a barrier to many other types of care. The whole system is under-
funded and under-resourced, and I would suggest that every child
in foster care deserves to have a medical home where they receive
high-quality care that is comprehensive, well-coordinated, and that
works very closely and in collaboration with the child welfare sys-
tem. I think that that would afford a high level of protection in
terms of enrolling children in clinical research trials. In our com-
munity, whenever a question comes up about an end-of-life issue
for a child, a surgical procedure that is being offered to a child,
bone marrow transplant or child with cancer who needs a more ad-
vanced protocol than is currently available as a standard of care,
those questions come back to our office where we are the primary
care doctor in the medical home. I think trying to change the whole
system of care for our kids so that it was much more modeled on
a medical home model would go a long way toward preventing
these types of issues.
Dr. FLEISCHMAN. Well said.
Mr. MCDERMOTT. If the Chairman would just give me 1 more
second. The database you are talking about, I remember when I did
some research when I was in my residency, and I found the data-
bases could give me two left-handed plumbers living in towns of
less than 20,000 people. Are you suggesting a national database for
all health care data so that we would then have that capacity to
do that kind of research? Do you think politically that is possible?
Dr. ELEISCHMAN. No. I am suggesting that we have a database
on all subjects of research in this country.
Mr. MCDERMOTT. Oh, just research.
Dr. ELEISCHMAN. That we ask IRBs to review research, and
we ask investigators to tell IRBs and then tell the government how
many subjects, what was the kind of research, what were the cri-
teria in which the IRB reviewed the research, and move forward
with it.
Mr. MCDERMOTT. Thank you, Mr. Chairman.
Chairman MERGER. Thank you. The gentleman from California
Mr. Becerra to inquire.
Mr. BECERRA. Thank you, Mr. Chairman. Thank you all for
your testimony. I want to go back to the gentleman of Washington’s
question, because I think it is the correct one. Is there something
we should be doing? My sense is that we are trying to find out if
there is this purgatory where children are where it is not clear if
they really should participate in these clinical trials, and we are
concerned that they actually may be used as a commodity in some
of these clinical trials. I am not sure if you have answered that
question for us to leave us with a feeling that there is something
we can do, or we needn’t do anything. So, if you can give us some
clarity, is there something we should do? If you say yes, please try
to give us a specific.
Ms. HARRIS. I think one of the questions that comes to mind is
is the determination of whether research carries minimal risk and
the child would directly benefit subjective? Who makes that deter-
mination? What are the criteria? That is one of the questions I
47
think that is unanswered, and that was sort of central to some of
the HIV/AIDS research.
Mr. BECERRA. Before anyone goes on, Ms. Harris, let me ask,
are you saying then that Wisconsin, since you are more restrictive
than other States, and I think my State of California is also very
restrictive in requiring some judicial order to allow a child, a foster
child, to participate, are you saying that there is a concern that,
in fact, there might be a problem in protecting that child suffi-
ciently through the IRB process without a child advocate?
Ms. HARRIS. Yes, and if there is, if there is, that right now
within the IRB process, there is lack of clarity with — in that deter-
mination.
Mr. BECERRA. Thank you.
Ms. SPEERS. I would suggest three items. One is to just rein-
force what Dr. Fleischman suggested, which is any IRB that is re-
viewing research involving children, that IRB should have exper-
tise in pediatrics; but more than just pediatrics, in the interests of
children so that it might not be a pediatrician. It might be a social
worker. It might be an individual school, someone who understands
the needs of children. That is not a requirement in the Federal reg-
ulations at this time. Secondly, the additional protections per-
taining to children in Subpart D are not universally adopted across
the Federal agencies that conduct or sponsor human research. Sub-
part D is followed by the Department of Health and Human Serv-
ices. It was added in 2001 to the Food and Drug Administration
regulation.
Mr. BECERRA. Who else would be part of that, what other agen-
cies?
Ms. SPEERS. There are 16 other agencies.
Mr. BECERRA. Can you give us those you believe should fall
under the jurisdiction of Subpart D?
Ms. SPEERS. I want to say also that the Department of Edu-
cation does have Subpart D. Those are the three that do, but the
other ones, in particular one is the National Science Foundation.
Mr. BECERRA. Do me a favor. If you could just submit those so
that way you can get to your third part, because otherwise I am
going to run out of time.
[The information was not received at time of printing.]
Ms. SPEERS. The third is I wanted to suggest that there should
be an education requirement for IRBs. IRB members now have no
education requirement under the Federal regulation. It would be
much easier for IRBs to follow the regulations and understand the
regulations if they had some type of education requirement.
Mr. BECERRA. Dr. Szilagyi, I hope I pronounced that correctly,
do you have anything you would like to add?
Dr. SZILAGYI. No.
Mr. BECERRA. A quick question then before I run out of time.
Is there any standard throughout that is applied, that should be
applied, a best practices standard that we could use?
Ms. HARRIS. I am not aware of an existing best practices.
Mr. BECERRA. Is it good policy to allow the various States to
come up with what they believe is the best practice for these deci-
sions in regards to foster children?
48
Dr. FLEISCHMAN. One very powerful method is that Office of
Human Research Protection has the ability to give guidance to all
IRBs around the country.
Mr. BECERRA. Does it do so?
Dr. FLEISCHMAN. They do. They have not yet done that in this
area. The Secretary has an advisory committee to that office on
human research protection.
Mr. BECERRA. Should they do so?
Dr. FLEISCHMAN. I believe they should, as well as to clarify for
Ms. Harris the definitions of minimal risk, and minor increase over
minimal risk, and prospect of direct benefit, which the Sub-
committee on children has already provided and requested that a
guidance be produced.
Mr. BECERRA. One last question as my time runs out. If the
best interest of a child is not upheld, who should be responsible?
Dr. FLEISCHMAN. Everyone. Starting with the investigators,
starting with those people in agencies who are responsible for those
children, and going back toward the IRB, the institution that con-
ducted that IRB. Ultimately, at the Federal level, there is some re-
sponsibility. The real responsibility stands at the local level.
Mr. BECERRA. Anyone else?
Chairman HERGER. Thank you. The gentleman from California
Mr. Stark may inquire.
Mr. STARK. Thank you, Mr. Chairman. Just a couple of com-
ments. Dr. Szilagyi, I am a little bit concerned. I appreciate your
idea that it is through experiments, and the poor children can get
health care, but I wonder is it right in this country, and this is just
an aside, should they have to be guinea pigs to get health care? I
think that is wrong.
Dr. SZILAGYI. I don’t believe I said that.
Mr. STARK. Well, you didn’t say that. To me it implies that. One
of the good things about getting foster children into these programs
is that they wouldn’t get health care otherwise. I am suggesting to
you that that is a travesty. It is has nothing to do with these rules,
but that is one of the travesties of having uninsured children.
Dr. SZILAGYI. Then I would like to clarify. What I intended to
say was that for some children in certain circumstances, and the
HIV/AIDS phenomenon of the early 1990s was one of those
Mr. STARK. Let’s move ahead, though. Dr. Szilagyi. the only
way for them to get certain kinds of care was actually for them to
be enrolled in studies because that was the only way to obtain
these drugs.
Mr. STARK. Going back, very quickly, and, Mr. Chairman, I ask
unanimous consent to put both subpart C and subpart D of 45(c)
in the record.
[The information is pending:]
Basically, there is a difference. Young was wrong. There are ad-
ditional protections for prisoners; and basically, if I can just para-
phrase in the time allowed, it says that all regulations relative to
prisoners will be enforced regardless of other regulations in this
subpart. It goes on to say that because prisoners may be coerced,
they have got to have an advocate; yet subpart D for kids, and that
is not there. There is in my mind a question. If you still had an
Eloise Anderson around someplace, she would sacrifice children
49
for — you don’t know who she was, do you? You dumped her from
Wisconsin, did the California, thank you very much, send her back
and give you three free kicks. There is a question that perhaps fos-
ter children are — present company completely excepted — you and
the Committee are an easy target because they are there, and they
may not have to go through as much pleading with the parent and
explaining because it is a much more institutionalized group of
children, and you are able to find research subjects in that popu-
lation. That worries me. It would be a simple thing, it seems to me,
for us — what is good enough for Haldeman, Erlichman or Martha
Stewart ought to be good enough for my kids, right? Prisoners can
have an advocate required; it doesn’t seem to prohibit us from
using prisoners in these cases. I think maybe we could make some
simple changes, which — in States other than the ones represented
here which don’t have such good protection. I think there are some
States, Mr. Chairman, where we find it has been more casual in
their outlook as to how foster children are protected. I don’t think
we would impose any great impact or regulatory burden by consid-
ering in this Subcommittee whether we might coordinate the re-
quirements for prisoners and children. I hope you all will have staff
look at these requirements, and we could ask the witnesses per-
haps to respond to us later whether the prisoner requirements
would unduly hamper research and the opportunity for children to
participate in these programs. Then we could sleep a little better
at night knowing that at least we put in the requirement, the chil-
dren would have adequate advocates in the program. If anybody
wants to disagree with that, that is fine with me, but that is what
I am reading here.
Dr. FLEISCHMAN. As long as you are aware of that, the Office
of Human Research Protection has just created the Institute of
Medicine broad-based study on prisoners research, and the Sec-
retary’s Advisory Committee is taking up that issue as well. There
is a broad-based review of research with prisoners that is going on
as we speak. We need to be sure to coordinate that thinking with
whatever thinking you have.
Mr. STARK. I think, Mr. Chairman, with foster kids, they don’t
have the complete freedom, just as a prisoner doesn’t, and it is that
minor extra protection that we might want to consider in any legis-
lation that you might consider, Mr. Chairman. I thank all of you
for taking the time, and your concerns. I thank you all for every-
thing, except Eloise Anderson. You can have her back.
Chairman HERGER. I thank the gentleman. Ms. Harris, beyond
participation in clinical trials, could you tell me about drug use of
children in foster care more generally? For example, who decides
whether children are to receive medications such as
antidepressants or stimulants, the doctors, foster parents, case-
workers, all of the above? What do we know about the medications
provided children in foster care; for example, what share are on
medication and for how long?
Ms. HARRIS. I can’t speak specifically to certain medications.
We can certainly get that information to the Subcommittee. The de-
termination is parents retain the rights of any other parent with
respect to children in Wisconsin’s foster care system, unless the
parent is incapacitated or for some other reason incapable of mak-
50
ing that decision. Then the court can grant authority for decision-
making, either a temporary — through temporary guardianship
through the system. Generally, even if the child is not physically
placed with the parent, the parent retains the right to make all de-
cisions with respect to all medical decisions.
Chairman HERGER. Thank you. Dr. Fleischman, the purpose of
this hearing this afternoon is that there has been some very seri-
ous allegations made recently, especially about the treatment of
children in New York City, in clinical trials for AIDS medicines in
the late 1980s and 1990s. These go to race and whether certain
children were targeted because of their race or their being in foster
care. Our purpose today is to review whether current protections
are adequate or not. Obviously, we are concerned about the allega-
tions that have been raised. You were not only there, but you treat-
ed many of these children and sat on the Institutional Review
Boards, whose purpose was to determine the propriety of their par-
ticipation. Would you care to comment directly about some of the
more inflammatory charges that have been made of late?
Dr. FLEISCHMAN. The charges saddened me. I thought they
were extremely inaccurate; that the doctors, the Institutional Re-
view Boards and the institutions caring for children with HIV and
AIDS were extremely sensitive to the areas of cultural sensitivity,
race, ethnicity, the concerns of poverty. Our children, all of our
children with HIV, the vast majority, were from poor families and
minority families. We were very sensitive to those issues. The IRBs
were extremely concerned. We believe we developed procedures
that protected their interests and enhanced their quality of life and
their lives in general.
Chairman HERGER. Thank you. I want to thank each of our wit-
nesses this afternoon for taking the time to appear here today. I
appreciate your help in understanding this issue further. With
that, the Subcommittee stands adjourned.
[Whereupon, at 3:55 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of Sheila Matthews and Gloria M. Wright, Ablechild.org, New
Canaan, Connecticut
Wards of the State: Protection of human subjects “Special Population”
Ablechild Background: a non-profit 501C-3 organization whose Board of Di-
rectors consist of doctors, teachers, psychologists, and other mental health
providers dedicated to protecting the health and well-being of children.
These true professionals wholeheartedly support parental rights, informed
consent (full disclosure), and a parent’s right to choose regardless of legal
status. We have spoken out on this issue in many media outlets: CNN Today
Show, CBS Evening News, Good Morning America, Hannity & Colmes, A&E
Investigative Reports, Montel Williams Show, John Walsh Show, Discovery
Health Gary Null Show, WXIA TV NBC Atlanta, NBC Health Page, Time
Magazine, New York Times, USA Today, G. Gordon Liddy Show, Sean
Hannity Radio Show, Armstrong Williams Show, Martha Zoller Show,
WDUN, The Riley Report Many Other Shows and Publications Numerous
Websites.
My name is Sheila Matthews and I am a Connecticut mother who testified before
the public health committee on the first law to prohibit schools from recommending
psychotropic “medication” to children as a requirement for attending school. I am
also the National Vice President and Co-founder of Ablechild.org a non-profit na-
tional parent organization that works on educating the public on the issues of in-
formed consent and the right to refuse psychiatric “treatment”.
51
Our organization is very concerned with the outcome of this hearing because we
hear directly from parents victimized by the trafficking of their children into clinical
drug trials while in state custody. Ablechild has documented cases of children that
have been placed on drugs, completely unaware if they are participating in a clinical
drug trial, and without knowing that they have the right to “opt out” of partici-
pating. The fact is, the State holds the responsibility of providing informed consent
to parents and children, and lacks any procedure to protect and safeguard this right.
A clear conflict of interests exists between the pharmaceutical industry and the
experimentation occurring on children within state custody. This fact is clearly dem-
onstrated by workshops sponsored by the pharmaceutical and biotechnology indus-
tries designed to optimize strategies for drug development and trials in children.
One such workshop was held in New Haven, Connecticut on May 19th-21st, 1997
and brought together representatives of the drug industry, government, and the aca-
demia.
The workshop was specifically designed to focus on “New Pediatric Regulations,”
“Vaccine Development,” “Strategies for Identifying New Gene Targets,” “Novel Drug
Delivery Systems,” and “Neuro-Behavioral Disorders”. What this workshop failed to
focus on was the informed consent process, the right to refuse process, and the spe-
cial rights afforded to the vulnerable population, “Wards of the State”.
Sponsors included Yale Department of Pediatrics and Yale Child health Research
Center New Haven CT, Yale Child Study Center, New Haven Connecticut, National
Institute of Child Health and Human Development, and NIH Bethesda, MD. Cor-
porate Sponsors included Bayer Corporation, Pfizer, Inc., SmithKline Beecham
Pharmaceuticals, Biological Division, Wyeth-Lederle Vaccines, and Pediatrics.
Our organization points out the problems that resulted from strategies designed
to target and exploit these children, strategies that were highlighted at the work-
shop in 1997.
The Connecticut Advocate reported these resulting problems in its June 5th, 2001
article, “Study Calls for Review of Psychiatric Drugs Prescribed to Kids.”
Within this news story, the authors of a new study questioned why 396 children
under 4 years old covered by Medicaid were prescribed psychiatric drugs. Some of
these children were less than 1 year old.
Trafficking children into clinical drug trials is a violation of basic human
rights. Past history of this United States human rights violation is clearly illus-
trated by one landmark case, Willowbrook that was brought to public light in 1987.
This case addressed the right to informed consent of any institutionalized person.
It is our hope that these hearings will reform this human rights violation and up-
hold their rights.
Ablechild.org
Hendersonville, NC 28791
May 18, 2005
Congressman Wally Herger
2268 Rayburn House Office Building
Washington, DC 20515
Dear Congressman Herger:
As a grandparent and a member and officer of Ablechild, a 501(C) 3 organiza-
tion, I wish to bring to your attention our cry for the protection of human rights
of foster children across Americal
Our organization frequently hears from parents across the nation that implore us
for assistance in the matter of the clinical trial/experimental drugging of their chil-
dren while in state custody and in foster care. These children have been placed on
clinical trial drugs without a legal advocate responsible for safeguarding their
health, nor their life. As minors these children are unable to opt out of these tests/
experiments, the parents have been denied their right to dissent and there obviously
are no procedures in place to safeguard the rights of the children.
Ablechild is aware of your committee’s investigative hearings into Child Protec-
tive Services which was held in March 2004. Wreckless endangerment of children
in the custody of most states across the nation became fairly apparent during those
hearings. Illegal seizure of many children was noted. Methods used and justification
to seize children from the safekeeping and love of their parents and thus placing
them in foster care was well exposed at that time. Now these very children are
being forced into clinical trials — or experimentation — while being forced to SUR-
RENDER THEIR HUMAN RIGHTS while at the same time endangering their
presentifuture health.
52
Congressman Herger, Ablechild calls upon your committee to enact a law where-
by all pediatric clinical trials, without express consent of the parents, be prohibited.
This law should include children in foster care and should not preclude those chil-
dren who are at home with their parents or custodial family members. Congressman,
the importance of such legislation goes beyond the giving of a pill to a child. This
matter is about Human Rights — and those rights of children have been
gravely sacrificed and the health and future of these children may have
been imperiled.
Ablechild stands ready to support you and your committee on behalf of America’s
children and we would appreciate having dialogue with you and/or your committee
members in this matter and others that greatly impact our America’s children and
their families.
Sincerely,
Gloria Wright
NC Vice President
Statement of Vera Hassner Sharav and John H. Noble Jr., Ph.D., Alliance
for Human Research Protection, New York, New York
On March 10, 2004, The ALLIANCE FOR HUMAN RESEARCH PROTECTION
(AHRP) filed a complaint with both the Food and Drug Administration and the fed-
eral Office of Human Research Protection (OHRP) when we learned that 36 Phase
I and Phase II AIDS drug experiments had been conducted on infants and children
who were under the guardianship of the New York City Administration for Chil-
dren’s Services (ACS). The children were living at Incarnation Children’s Center, a
foster care facility under contract with ACS and the Catholic Archdiocese. We had
reason to believe that the experiments were unethical, illegal, and coercive — and
that federal regulations have been violated. We did not know at the time that chil-
dren in foster care nationwide were subjected to research exploitation at prestigious
medical research institutions.
Historically such children have been abused and exploited in medical experi-
ments — for that reason, federal regulations were enacted to restrict the use of foster
care children in research. The Associated Press confirms that for more than two dec-
ades, government officials colluded with hospitals and researchers to facilitate the
enrollment of children who were in the care of the state for experimental drug
trials. Nationwide, an estimated 698 to 1,388 foster children were used to test ex-
perimental AIDS drugs — at least 465 of those children were in the care of NYC’s
ACS — almost all were children of color. How ironic it is that children, who were
placed by the courts into the protective custody of foster care agencies pursuant to
the provisions of the Adoption and Safe Homes Act of 1997, should end up further
victimized by their caretakers.
These children were exposed to pain, risks, and potentially harmful experimental
drugs — the children suffered, some died. In some cases the children were diagnosed
with HIV infection — in other cases infants were merely “presumed” to be HIV-in-
f©ct0ci
The Code of Federal Regulations (45 CFR 46.409 and 21 CFR 50.56) prohibits
subjecting children who are wards of the state to experiments involving greater than
minimal risk:
(a) Children who are wards of the State or any other agency, institution, or entity
can be included in research approved under 46.406 or 46.407 only if such research
is:
(1) related to their status as wards; or
(2) conducted in schools, camps, hospitals, institutions, or similar setting in which
the majority of children involved as subjects are not wards.
(b) if the research is approved under paragraph (a) of this section, the IRB shall
require appointment of an advocate for each child who is a ward, in addition to any
other individual acting on behalf of the child as guardian or in loco parentis.
The advocate shall be an individual who has the background and experience to
act in, and agrees to act in, the best interests of the child for the duration of the
child’s participation in the research and who is not associated in any way (except
in the role as advocate or member of the IRB) with the research, the investigator(s),
or the guardian organization.
The Phase I and Phase II experimental drug and vaccine trials in question were
unrelated to their status as wards — the NYC-ACS enrollment guidelines applied to
foster care children only. The ACS guidelines falsely stated that the trials posed
53
“minimal risk,” and the guidelines clearly focused on facilitating rapid enrollment
of as many foster children as possible — rather than ensuring that the trials were
in the children’s best interest: [Attached]
“ACS will review clinical trial protocols for HIV-infected children as soon as such
protocols become available, before a specific hospital decides to participate in the
study. The National Institutes of Health (NIH) and pediatric AIDS specialists
throughout New YorkState will make ACS aware of protocols as soon as they are
in final form, before hospitals are ready to enroll children. This procedure will expe-
dite ACS’ decision-making even before physicians are ready to start treating chil-
dren in the protocols.”
The Associated Press confirmed our suspicion that most of the children in the care
of ACS did not have a personal advocate — as required under federal regulations. In-
deed, of the 465 NYC children in the experiments, only 142 had an advocate. Fur-
thermore, ACS even waived the requirement for individual consent for these chil-
dren — encouraging them to be herded en masse into drug trials as if they were ani-
mals.
Phase I and Phase II drug experiments involve the highest level of risk, uncer-
tainty, and discomfort — the safety and toxicity of drugs as well as maximum dose
tolerance are tested in these trials. Experiments at that testing stage are unlikely
to have any direct benefit for the children in whom the drugs are tested. In some
trials children were diagnosed with HIV infection — in some cases infants were mere-
ly “presumed” to be HIV-infected:
#292: A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity
of a Seve n Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected In-
fants
#345 A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Chil-
dren, last amendment 3/13/2000.
“Replacement infants . . . are either presumed HIV infected or have already been
shown to be HIV-infected . . .”
Infants and children were exposed to experimental HIV vaccines — which have
b 60 ri succBSsfiil"
#218 A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and
Immunogenicity of Recombinant Envelope Proteins of HIV-lgpl60 and gpl20 in
Children >=1 Month Old with Asymptomatic HIV Infection.
Although more than 4 AIDS drugs had never been tested in children, foster care
children were exposed to an 8 drug cocktail “some at higher than usual doses”
(which was reduced to 7 drugs because of “significant toxicity” 11/9/2001).
#1007 Multi-Drug Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS
Patients: A Phase I Proof of Concept Trial
Among the drugs tested in foster care children, is Nevirapine, a drug whose safety
has been the center of controversy. [AP] Because Nevirapine confers resistance fol-
lowing even a single (low) dose, its manufacturer cautions that its use should be
restricted to “previously untreated women with HIV infection who present at labor”
for the prevention of mother-to-child transmission of HIV. Yet, 4 to 17 year old chil-
dren in foster care were exposed to Nevirapine.
A Phase I trial of a Glaxo Wellcome drug, Valacyclovir hydrochloride was termi-
nated in 1997 — Why? Typically, trials terminated at such an early stage show unac-
ceptable levels of toxicity.
The Associated Press reported: “Some foster children died during studies, but
state or city agencies said they could find no records that any deaths were directly
caused by experimental treatments.” It is not for those city agencies to decide the
cause of death. ACS Commissioner, John B. Mattingly, testified before a City Coun-
cil General Welfare Committee, that he knows of just 19 children — out of 465 — who
remain within the NYC foster care system.
In addition, a series of recent investigative mediareports from Texas, Florida,
Ohio, New York, California, Illinois, raise concerns that over 50% of all children in
foster care are currently being prescribed untested, experimental combinations of
powerful, mind altering, psychotropic drugs — including antipsychotics (e.g.,
Risperdal, Zyprexa), anticonvulsants (e.g., Depakote, Neurontin), antidepressants
(Zoloft, Peixil, Prozac, Celexa and others), tranquilizers (Klonopin, Xanax), stimu-
lants (Ritalin, Adderall), as well as heavily sedating drugs such as the anti-hyper-
tensive medication clonidine. These prescribing patterns are essentially uncontrolled
experimental drug trials. [See: The Columbus Dispatch series by Encarnacion Pyle.
Forced medication straitjackets kids, Sunday, April 24, 2005 http://
www.dispatch.com/reports-story. php?story=dispatch/2005/04/24/20050424-Al-
OO.html.
Clinical trials approved by the FDA study only a *single* drug given in tightly
controlled dosages. Combinations of two and three or more different psychotropic
54
drugs have simply never been studied in a rigorous and responsible manner. Fur-
thermore, the foster parents and social workers who are mostly entrusted with su-
pervising these children have less than rudimentary knowledge about these drugs’
adverse effects, and even less skills in monitoring these children to avoid dangerous
drug reactions. This is of course less than the protection afforded subjects in ordi-
nary clinical trials. It is worth repeating: none of these idiosyncratic drug combina-
tions — called polypharmacy — have ever been studied by any responsible government
or other agency, and the children receiving them may be considered guinea pigs in
a gigantic uncontrolled medical experiment.
How can the Congress fail to take strong corrective action?
The public has a right to know:
• How many children in foster care have been enrolled in clinical trials?
• What happened to foster children who were used as human guinea pigs?
• What adverse effects did the children suffer during and after participation?
• How many children died during the experiments?
• A question has been raised about the size of the cemetery plot in which children
in Acs custody are buried: Were any children buried in mass graves?
• What were the specific sources of funding for these Phase I and Phase II clinical
trials?
• Did the foster care agencies or foster families receive pa3mient, fees, or other
rewards for enrollment of the children in these trials?
• How much money was paid to the researchers and participating hospitals?
• What happened in 2001 that the AIDS drug trials in foster children were
stopped?
• What other drug trials are being conducted on foster children?
The other questions we pose below suggest that there may have been a break-
down in the implementation of the Adoption and Safe Families Act and/or related
federal law governing the protection of children in foster care. Our questions, by ex-
tension, suggest that the Council on Accreditation of Family and Children Services
(COA), and one of its two founding organizations, the Child Welfare League of
America (CWLA), may not be meeting their obligations.
Child protection falls within the purview of the juvenile and family court system,
which remands abused and neglected children into the care of public and private,
non-profit foster care agencies. In our view, the courts have ultimate jurisdiction
and responsibility for what happens to these vulnerable children.
The Congress may want to consider a dual approach in dealing with the issues
at hand. Child welfare laws operate by regulating the care-givers. Child abuse re-
porting laws, for example, require health, school, and social service personnel to re-
port suspected child abuse. If such laws were to define “suspected child abuse” to
include enrollment of foster children in Type I and Type II clinical trials, in viola-
tion of the protections afforded by 45 CFR 46.409 and 21 CFR 50.56), there would
be many more eyes watching to protect children from overreaching biomedical re-
searchers who, history has shown, have abused their authority to exploit children
in foster care.
• Were there violations of the provisions of the Adoption and Safe Families Act
and/or related child welfare legislation by officials of the foster care agencies
that permitted enrollment of foster children in Phase I and Phase II clinical
trials?
• Should not the supervising foster parents and/or social workers have reported
suspected child abuse in these high risk. Phase I and Phase II clinical trials
of experimental drugs and vaccines?
• What training, if any, is provided to supervising foster parents and/or social
workers about the conditions that must be satisfied by reference to 45 CFR
46.409 and 21 CFR 50.56 in order to justify enrollment of foster children in
ANY biomedical research involving greater than minimal risk?
• Is there a need for new federal legislation that would amend the Adoption and
Safe Families Act and/or 45 CFR 46.409 and 21 CFR 50.56 to expressly define
children in foster care a “protected class,” whose enrollment in ANY biomedical
research would trigger appointment of an independent research ombudsman
under the supervision of the juvenile or family court that remanded the foster
child into state custody?
Finally, if, as we argue, the courts have ultimate jurisdiction and responsibility
for what happens to children whom the courts remand to the protective custody of
state and private, non-profit foster care agencies, then the Congress might wish to
consider amending the existing requirement for the appointment of a child advocate
by the IRB pursuant to 45 CFR 46.4.09 and 21 CFR 50.56 to require instead that
55
the child advocate be appointed by and be held accountable to the court of original
jurisdiction for foster children who may be subjected to biomedical research involv-
ing greater than minimal risk. The courts, we believe, are the last recourse that fos-
ter children have to protect them from the predatory practices of those who would
exploit and take advantage of their vulnerability. We should remind ourselves that
the measure of a society is how it treats its most vulnerable citizens.
Statement of Cheri Carlene Campbell, American Family Rights Association,
Morongo Valley, California
This information has been assembled to help equip those attending [and those
who will influence the outcome of] the hearing on June 9, 2005 in an effort to pro-
tect the greater society. You must look closely at the problems surrounding Dept,
of Children’s Services [DCS] to discover that the real problem has nothing to do
with how funding is related to outcomes for children. It is your moral duty to find
a solution to this Nationwide dilemma which has been plaguing America for dec-
ades.
On March 13, 2004 U.S. Congressman Joe Baca gave the victims of DCS a voice
and sent 163 evidence books to Washington. The people need to know what our
elected officials have done to protect us and our Posterity since receiving the docu-
ments proving the ministerial ineffectiveness of DCS.
Victorville, CA — Daily Press: “United States Accuses 14 Nations of allowing Mod-
ern Day Slavery” reads: U.S. criticizes 14 other nations of not doing enough to stop
the modern day slave trade (prostitution, child sex rings, and forced laborers) in-
volving 800,000 annually. Condolezza Rice stated, “The U.S. has a particular duty
to fight this scourge because trafficking in persons is an affront to the principles
of human dignity and liberty upon which this nation was founded. U.S. spends $96
million to help other countries combat trafficking.” The U.S. is not included on the
list although R. Miller said the country is far from immune . . . and includes the
U.S.— June 4, 2005
American children and their families are the victims I speak of. Children are rou-
tinely seized by DCS agents who blatantly violate Laws in place to protect the fa-
milial bond which include the California and U.S. Constitutions! DCS hides their
practices under the confidentiality clause, which was designed to protect families re-
ceiving public assistance from embarrassment, not hide their devious practices. DCS
is a Government sanctioned agency that receives federal and state funding in ad-
vance for obtaining children, which clearly makes this a problem for each branch
of Government.
I agree with Congressmen Merger who believes there should be better outcomes
for the safety and well being of our children. However, even after thousands of com-
plaints from victims of abuse under color of law by DCS, our elected officials con-
tinue to look for a solution in the wrong place.
Congresswoman Nancy L. Johnson shared the reasonable solution of frontloading
the money to help keep the family in tact. This would not only save the government
billions of dollars, it would effectively spare the greater society a whole generation
of shattered children and adults who have no confidence whatsoever for those in au-
thority.
The problem is multi-faceted and although they appear to be complex, these
issues are simple to correct. Cross references from legal authorities have been used
to substantiate the current immoral practices and motives used to obtain, detain
and adopt our children without Due Process which include: California Benchguide
[CAB] 100 Juvenile Dependency Initial or Detention Hearing — revised 2003; Welfare
and Institutions Code [WIC]; California Rules of Court [CRC]; CA Dept, of Social
Services Manual — Child Welfare Services Program [CWS]; Family Code [FC]; Na-
tional Association of Social Workers — Code of Ethics [NASW].
Removal of a child: Federal Law mandates there must be a court order or vol-
untary surrender. Cathy Cimbalo [San Bernardino Director of DCS] states her social
workers must have the agreement of a police officer and a court order. When I of-
fered to show the court order during the unjust removal of our grandchildren. Dep-
uty Porter stated “I don’t care what papers you have, we’re taking the children!”
Out of thousands of ‘removals,’ no victim has ever seen a court order and they have
not voluntarily surrendered their child! In fact, many have been arrested for ver-
bally trying to dissuade the police officer during the unjust removal of their chil-
dren! CWS 361(b) no dependent child shall be taken from his parents/guardian
where he resides unless the juvenile court finds clear and convincing evidence of:
(1) substantial danger; no reasonable means child can be protected without remov-
56
ing him; WIC 300(e) [child has suffered severe physical abuse] shall constitute
prima facie evidence minor can not be safely left in custody of parent/guardian with
whom the minor resided at the time of injury. Most children have no injuries, which
is proven during the medical exam performed after removal. This exculpatory evi-
dence is deliberately withheld, and is punishable pursuant to Government Code
820.21 which strips away supposed immunity! CAB — 100.9 Initiating the Hearing —
If the social worker determines that the child is to be detained, a petition must be
filed with the Juvenile Court [JC] clerk, who must set the matter for hearing on
the detention hearing calendar . . . WIC 311(a) Filing petition for retention of cus-
tody . . . Confrontation by and cross-examination of witnesses [Due Process] Most
[if not all] parents/guardians do not contest due to threat [“if you contest termi-
nation of guardianship, your children will be separated, adopted out and you’ll never
see them again!”], duress and coercion; CRC 1442(b) — Time limit on custody, filing
petition — detained child must be released within 48 hours . . . if no petition has
been filed. The contents of the petition are prescribed by WIC sect. 332 — A petition
to commence proceedings ... to declare a child a ward or a dependent child of the
court shall be verified . . . and CRC 1407 — The petition shall be verified and may
be dismissed without prejudice if not verified. An unverified petition may be dis-
missed without prejudice. The laws are in place, but they are constantly violated!
An internal review is DCS’ only watch dog, as they claim confidentiality prohibits
‘outside’ review.
Perverse financial incentive: WIC 319(c) If the matter is continued pursuant to
Section 322 or for any other reason, the court shall find that the continuance of the
child in the parent’s or guardian’s home is contrary to the child’s welfare at the ini-
tial petition hearing or order the release of the child from custody. CAB JUDICIAL
TIP: Failure to make this finding [contrary to the child’s welfare] may cause perma-
nent loss of federal funding for foster care. Herein lies the problem: financial incen-
tive; empires being built off the backs of our children of tender years!
Prima Facie Evidence: Most Americans still trust the Justice System even though
millions of its victims exist. CRC 1445(a) Requirements for detention — (1) a prima
facie [Latin for: at first view] showing has been made that the child is described
by WIC 300 [child abuse, neglect, etc], (2) One or more of the grounds for detention
in CRC 1446 is found; CRC 1446(a) Grounds for detention — There is a substantial
danger to the child’s physical health, or the child is seriously emotionally damaged
and removal is the only way to protect the child. DCS agents have created “emer-
gencies” believing they will never be forced to prove the petition’s allegations. Most
court reports and verbage are almost identical in all cases.
Furthering the destruction of the familial bond without Due Process is dem-
onstrated in: CRC 1447 Detention hearings; prima facie hearings (d) [Hearing for
further evidence; prima facie case — If the court orders the child detained, and the
child, a parent, a guardian or counsel requests that evidence of the prima facie case
be presented, the court shall set a . . . hearing within three court days to consider
evidence of the prima facie case, or set a jurisdiction hearing within 10 court days.
If at the hearing petitioner fails to establish the prima facie case, the child shall
be released from custody. WIC 321 If the minor, a parent or guardian or the minor’s
attorney . . . requests evidence of the prima facie case, a rehearing shall be held
within three judicial days to consider evidence ... if [it] is not established, the
minor shall be released from detention. Most victims do not have a clue these laws
exist until it is too late and although Cathy Cimbalo continues to say “we must
trust the justice system” and that her “460 ‘professionals’ only do what the court
says,” we have found this to be a deadly combination. Social worker’s libelous re-
ports are not challenged and are ‘found to be true’ at the next hearing, we are rarely
allowed to speak in court and our public defenders do not defend our rights!
In 2004, the Federal Government provided more than $7 billion in dedicated
funds for child protection. The bulk of these funds [almost $5 billion] supported chil-
dren who had been removed from their homes. All this money spent to “protect”
those in foster/adopt/group homes where far too many children have been killed or
tortured, proves that more money is not the solution. Maybe it’s time to try a new
approach. Carefully consider what you have read. Our right to fair and honest gov-
ernment, government accountability to the people, and redress has thus far been de-
nied. More importantly, our God given inalienable rights have been violated!
You must invoke the power to open DCS files for the sake of investigating the
current immoral and illegal practices [full Thesis available connecting the above
Legal references]. We the people nominate expert family advocate Bill Tower and
Jane Flickinger at Pacific Justice Institute as overseers of this Commission.
We have sought redress from the proper chain of command and found no remedy.
San Bernardino [S.B.] County Board of Supervisors were duly noticed regarding
DCS practices of non-compliance to State and Federal mandates; were informed that
57
DCS’ ministerial ineffectiveness is causing irreparable damage to the greater soci-
ety; and Chairman Dennis Hansberger publicly stated ’his hands are tied’. S.B.
Grand Jury received 13 official complaints against DCS via certified mail in 2004
and replied, “After a thorough review [of complaints, evidence], we have decided not
to investigate.” S.B. Assistant District Attorney Mike Risley was given copies of
these complaints, but no remedy or acknowledgement has been given to date.
In conclusion, I must remind you that the U.S. has a particular duty to fight this
scourge. Trafficking in persons is an affront to the principles of human dignity and
liberty upon which this nation was founded. The following questions remain unan-
swered: How will this Government offer a gentle return of our children when the
mask is torn off these “child protectors”? How many more Logan Marr’s will have
to die or be tortured while in the State’s care before DCS is completely reformed
and held accountable? June 9th is our granddaughter Rainya’s 7th birthday and al-
most 2 years since we’ve seen our beautiful grandchildren . . . today is a great day
to start protecting your constituents!
Thank you for your quick resolve in stopping this egregious silent epidemic that
is now shouting for remedy. Your response, nomination of Bill Tower and Jane
Flickinger to oversee the investigation of DCS and its inter-related service practi-
tioners, and an outline of remedy will be expected within 20 days of this
communique. We are not just a few disgruntled people, we are millions that are
growing weary. We will not be comforted for the unjust loss of our Posterity. You
must assure the people that our Nation’s officials are going to stop this modern day
domestic terrorism and pledge to restore democracy in our own backyard.
Statement of Linn Asplund, Waterbury, Conneetieut
Thank you for considering my testimony. When me son was 10 years old, he was
attending Washington School in Waterbury, CT. He started having problems in the
beginning of third grade, September 1999. He was being picked on and bullied by
the other children. His grades started suffering and he too started having discipline
problems. This bullying was brought to the schools attention, but it still went on.
The principal suggested a PPT. I agreed and at the first PPT I agreed to have him
tested. I was then told he was “LD” (Learning Disabled), but it ‘was not that bad.’
I told the school I wanted him to go to a school where they had smaller classes in
which he could learn at his own pace and not be picked on. I knew of schools with
such classes. I was denied this and told by the Special Education Supervisor there
was no such class. Next they told me they wanted him to see a psychologist for a
psychological evaluation, I agreed. I obtained a copy of the evaluation. My son told
the Doctor that he had no friends at school. He liked it better at home and would
wake up repeatedly at night with thoughts of how to quit school. By this time Dr.
Abramavich said my son was psychotic and needed to be medicated. I refused. The
next thing I knew, DCF (Department of Children and Families) was at my door tell-
ing me the school said my son has special needs that need to be taken care of. I
still refused the psychiatric drugs. I brought him to “child guidance” and was told
that he was a normal child.
After several visits form DCF I still refused to drug my son. On March 16th 2000,
I found court papers on my doorstep. In them my husband and I were charged with
abuse and neglect and were informed that DCF was going to take our son from us.
Later that day a social worker and police officer arrived and took him away.
Two weeks later, DCF placed him in Waterbury Hospital where Dr. Edwards gave
my son Haldol and Attavan — mind altering drugs not approved for use in children.
A few days after this. Dr. Mennessen put him on 100 mg of Wellbutrin a day; also
not FDA approved for use in children. When I asked Dr. Mennessen why he was
giving my son this drug without my consent, his reply was “we need a number of
cases to get it FDA approved.” Some of the side effects I saw were loss of hair, dry
& scaly skin, large hive like rashes and very pale skin. While in DCF’s care my son
lost weight and appeared malnourished.
There were numerous, outright lies in the documents that DCF had from the ini-
tial “anonymous” report from the school, I can provide this information and numer-
ous other internal DCF documents regarding my sons “treatment” should you re-
quire it. This of course is a very brief summary of what happened to my family.
I finally got my son back from DCF in August of 2002. This entire nightmare began
because I refused to put my son on dangerous, mind-altering drugs.
58
Statement of Alexandra Yoffie, Child Welfare League of America
CWLA STATEMENT ON PERMISSIONS FOR CHILDREN IN FOSTER CARE
TO PARTICIPATE IN TREATMENT RESEARCH FOR HIV INFECTION
The Child Welfare League of America and its nearly 900 member agencies believe
every child and youth is unique, has an intrinsic value to society, and is entitled
to have their basic care needs met, to be nurtured and protected, to heal when harm
is done, and to have the opportunity to develop to his or her potential. Ensuring
that each child receives needed primary and preventive health care is an essential
part of meeting these universal needs.
CWLA’s Standards for Health Care Services for Children in Out-of-Home Care
serve as a guide for the delivery of routine and specialized health services to chil-
dren in foster care and assert that these children have human rights that should
be protected. Because of the vulnerability of children in foster care and the responsi-
bility of the child welfare agency toward children in its care, recognition and safe-
guarding of these rights are foremost considerations.
Concerns have been expressed regarding states that have allowed children in fos-
ter care to receive experimental treatments for HIV infections without adequate
safeguards. CWLA’s Standards of Excellence for Family Foster Care Services provide
guidance in this area, stating, “The foster care agency should obtain written consent
[for medical care] from the child’s parents, or alternatively, from the court. . . . Par-
ents should grant written consent for their child’s medical care,” and for those chil-
dren whose parent’s rights have been terminated, the agency “should obtain written
consent from the courts.” This provision applies to all forms of medical care, includ-
ing treatment for HIV infection.
Allowing children in foster care to receive experimental drugs for the treatment
of HIV infection without providing an independent advocate to protect and ensure
the child’s safety and well-being-, is contrary to CWLA’s Standards for Health Care
Services for Children in Out-of-Home Care and our Standards of Excellence for Fam-
ily Foster Care Services.
As of December 2002, 821,470 adults and adolescents, and 8,804 children under
age 13, had been diagnosed with HIV/AIDS in the United States. Many children,
particularly those with HIV/AIDS, lack the kind of health care coverage that would
allow them to receive state-of-the-art medical care. Children in foster care should
not, as a matter of course, be denied access to appropriately reviewed and approved
treatment research. Nonetheless, it is in their best interests for the parents or
guardians and the child, when appropriate, to participate to the fullest extent pos-
sible in the development and implementation of the health care plan so that each
child’s unique needs and concerns are considered in any treatment decision.
We encourage all concerned to take this opportunity to more comprehensively ex-
amine the health care needs of children in foster care, including those who are dis-
abled or have mental health needs. In many instances, these children are without
adequate care to address their treatment needs. Priority must be given to providing
the advocacy and protections that would help ensure all children in foster care re-
ceive needed services so they might best heal from the harms of child abuse and
neglect
Jacobi Medical Center
Bronx, New York 10461
May 17, 2005
Congressman Wally Herger
Chairman, Subcommittee on Human Resources
Committee on Ways and Means
To the Committee:
I am currently the Director of Pediatric HIV Services at Jacobi Medical Center,
a member of the NYC Health and Hospital Corporation, located in the Bronx, New
York and have a pediatric HIV provider in the Bronx for over 20 years. Our pro-
gram is one of the largest single site programs in the United States and provides
integrated, comprehensive, multidisciplinary care to HIV infected children and HIV-
exposed, uninfected children as well as integrative care for infected adults and other
family members. As the Director of a recognized HIV Center of Excellence, our pro-
gram has worked closely with foster care agencies and the NYC Administration for
Children’s Services in managing the healthcare of infected children in foster care.
In addition, I have been involved in clinical trials involving HIV-infected children
as a member of the NIH funded Pediatric AIDS Clinical Trials Group (PACTG)as
59
well as a site investigator in clinical trials sponsored by pharmaceutical companies.
I am currently the Chairperson of the PACTG Primary Therapy Research Action
Committee which oversees HIV therapeutic treatment protocols sponsored by the
PACTG and NIH.
I would like to present a brief personal historical synopsis of how therapies for
HIV-infected children have evolved since the first description of the pediatric HIV-
epidemic since its inception in the early 1980’s. At that time, most HIV-infected chil-
dren entered care as a result of clinical conditions which resulted from their HIV
associated immunodeficiency. Treatment focused on the child’s clinical symptoms
such as anti-fungals for thrush, nutritional support for weight loss and antibiotics
for bacterial infections or pneumocystis carinii pneumonia (PCP) but without thera-
pies directed at the underlying illness (now known to be HIV), the immunodeficiency
progressed, the child deteriorated and, frequently, death ensued. For example, in
1989, I personally attended 1-2 funerals per month for children or their parents
who were in our care.
Late in the 1980’s, there were rays of hope as new therapeutic agents, with lim-
ited but real efficacy, began to emerge. Unfortunately, due to many fiscal, practical
and regulatory reasons associated with drug development for FDA approval, chil-
dren did not have availability to these agents for 1-3 years after they were available
for use in adults. The only way for an HIV-infected child to gain access to AZT
(zidovudine, Retrovir) was through a compassionate access protocol sponsored by the
manufacturer, which required an informed consent by a guardian or parent. While
this agent, as monotherapy, has extremely limited efficacy, for many, especially
those who were very ill and rapidly deteriorating, the alternative therapy was no
therapy. I can remember giving out the first pediatric AZT bottles to children and
their families during our 1989 Christmas party and the joy, tears and hugs that ac-
companied this “gift.” To the families and children, it was the first concrete impres-
sion that there was hope that this therapy, or future ones, would significantly pro-
long lives. At that time, if there was no mechanism available for obtaining consent,
many children in foster care would not be afforded this therapy, subsequent thera-
pies and, the hope, for clinical improvement and life extension.
In fact, this hope has been born out as demonstrated by HIV survival data (both
pediatric and adult) throughout the medical literature as well as statistics from the
CDC. On a more local level, our program is providing care to over 250 HIV-infected
children; over the past 12 months only 1 child has died. Some 50% of children in
our care have “undetectable viral loads” which suggests suppression of HIV replica-
tion and, in general, the majority of children in our care, are immunologically (as
measured by CD4 numbers and percentages) healthier now than they were in 1993.
While all therapies have potential and real toxicities, especially HIV medications,
these children are significantly healthier now than in the past and most are fully
involved in school, after school and other activities shared by healthy children.
I am in total agreement with the need for well defined systems to protect the
rights of children in foster care systems including the appointment of an inde-
pendent advocate for the child. However, I strongly believe as a health care profes-
sional caring for children with a chronic, life threatening illness, that a reactionary
posture in response to localized cases where some administrative oversight has been
missed would be an ethically unacceptable position for our society. How can one
refuse therapy to a child of a therapy which has heen demonstrated, in rigorously
controlled clinical trials, to be effective, simply because there is no one legally capa-
ble of signing consent for a trial which makes that therapy available? If you are HIV
infected, severely immunocompromised and resistant to all available therapies,
shouldn’t society be able to provide a mechanism which balances the potential for
clinical improvement and well-being for this child with a mechanism that respects
their rights as a participant in a clinical trial? As an HIV clinician, I have experi-
enced the pain and suffering associated with the lack of access of therapies.
I would also like to quickly comment on some of the allegations about the content
of many of the clinical trials in which children in foster care may have been partici-
pants. In NYC, the ACS had strict guidelines for approving clinical trials for chil-
dren: the bottom line was that the trial had to provide the potential of benefit for
that individual trial. For example, foster children in NYC, in the absence of mater-
nal consent, were not allowed to participate in the PACTG 219 study which was a
long-term, natural history study where data was collected during regularly sched-
uled visits. While the result of this study has benefited HIV infected children, there
clearly was no benefit to the individual child.
However, the Alliance for Human Research Protection listed in their 3/10/05 letter
to the OHRP and FDA that foster children were inappropriately enrolled into nu-
merous NIH-PACTG trials. Included in this list was PACTG 377 of which I was
the co-chairperson. This trial, a Phase PII (not purely a Phase I) trial, strategically
60
compared a number of therapeutic regimens for advancing the treatment of HIV in-
fected children when contrasted with standard of care. This study was linked to
PACTG 338 which demonstrated that a protease inhibitor containing regimen was
superior to the existing standard of care (two nuclosides). Importantly, these studies
were invaluable as they contained provisions that the first 8 children in each arm
participate in an intensive pharmacokinetic (pk) evaluation to ensure that the dos-
ing was appropriate when compared to drug exposure that had been demonstrated,
in adults, to be safe and effective. This component of the study, which required it
to he partially labeled a Phase I study, protected the study participants as dem-
onstrating the correct dose prevented the overdosing of children which would lead
to increased toxicity or underdosing the child which would lead to inadequate drug
exposure and rapid development of resistance to that therapy and, potentially, other
agents in that treatment (i.e.; protease inhibitor) class. These studies clearly dem-
onstrated that children metabolize many of these agents much more rapidly than
adults and that to achieve equivalent efficacy with adults, drug dosing in children
needed to he higher than one would expect.
In fact, it was data from this study and other studies which were important in
the signing, hy President Bush on 12/3/03, the Pediatric Research Equity Act of
2003 (S. 650/H.R. 2857), which restores the protections of the Food and Drug Ad-
ministration’s (FDA) 1998 Pediatric Rule. This legislation was hailed as a necessary
safety net for children.
In addition to ensuring that the dosing was correct (the protocol provided provi-
sions for dose modification if needed from the pk evaluation), these studies also con-
tain extensive, real time, safety evaluations and patient management requirements
to protect the health of children on the study. The information concerning the safe-
ty, dosing and efficacy of therapies included in this study, and others, has signifi-
cantly advanced our knowledge about treating pediatric HIV infection. This informa-
tion has been essential for advances in care which have been translated into im-
proved health and survival for children residing in the developed world. This, I see,
every day, when I walk into our outpatient pediatric HIV clinic and am greeted by
healthy looking, HIV-infected children, adolescents and young adults. Without early
access to therapy for all, including those in foster care, I do not believe that this
would have heen possible.
The proper response for future children living in foster care with chronic, terminal
illnesses should not be to have policies which prohibit and withhold therapies. In
1986, there were only a handful of people who thought that an HIV-infected child
would survive to adulthood. This is now common in the Bronx.
We just need to be more diligent in ensuring that successful policies and proce-
dures are in place to protect the rights of these children. Their rights, however, in-
clude having access to therapies that provide hope.
If needed, I am willing to work with this subcommittee, on this or any related
matter.
Sincerely,
Andrew Wiznia
Director of HIV Services
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland 21205
May 31, 2005
Representative Wally Herger, Chairman
Representative Jim McDermott, Ranking Member
Subcommittee on Human Resources
Ways and Means Committee
United States House of Representatives
Washington, DC
Dear Chairman Herger and Ranking Member McDermott,
We are aware that the Subcommittee on Human Resources of the House Ways
and Means Committee is reviewing the required procedures for protecting children,
including children who are wards of the state, when they become subjects in re-
search studies. I am writing to describe briefly the procedures used by the Institu-
tional Review Boards (IRBs) of this School to ensure that all children, including
wards, receive the additional protections required because of their vulnerable status.
I also wish to convey our strong support for the current federal regulations that gov-
ern research that involves children (45 CFR 46, Subpart D).
61
It is the understanding of our IRBs that the principle of justice, as described in
the Belmont Report, requires that all populations, including children, have the op-
portunity to take part in research and to share in its benefits. Furthermore, we sup-
port the strong recommendations of both the American Academy of Pediatrics and
the FDA that research on children is essential in order to determine how new find-
ings can be safely and most effectively used for their benefit.
To achieve these objectives our IRBs require that children be included in all of
this School’s human research activities unless there are specific scientific or ethical
reasons for excluding them. Following the principle of justice, we also require that
all children have equal opportunity to take part in research unless, again, there are
scientific or ethical reasons for excluding particular individuals or members of spe-
cific groups or populations.
When reviewing proposed research that would include children our IRBs follow
very carefully the requirements of Subpart D to determine the category of research
and the requirements for consent and assent (46.404, 46.405 or 46.406). The IRBs
focus especially on the assessment of risk to the child and on the prospect for direct
benefit for the child. Our assessment of risk is, if an 3 dhing, overly cautious in favor
of the child, and the prospect for direct benefit, if any, is consistently weighed
against this cautious assessment of risk. We believe that the categorizations made
by our IRBs are consistent with the federal requirements and, more importantly,
ensure appropriate protections for each child.
In accord with the position described above, we firmly believe that children who
are wards of the state deserve the opportunity to participate in research, and espe-
cially so when they suffer disproportionately from the condition being studied, an
example being HIV/AIDS. We would emphasize, however, that wards are not tar-
geted for inclusion. Rather, their status as wards is simply coincidental to their
being eligible for enrollment in the study. We also share the view that children who
are wards of the state require special protection because of their uniquely vulner-
able situation. We believe, however, that this is adequately ensured by the require-
ments outlined in 46.409, which require an advocate for each child involved in a
study categorized as involving greater than minimal risk and having no prospect of
direct benefit for the child (46.406). In our view, extending the requirement for an
advocate to studies that are greater than minimal risk but having the prospect for
direct benefit for the child (46.405) would create a substantial barrier to conducting
such studies while providing no clear added protection for the child.
We hope that these comments and our strong support for maintaining the current
federal regulations concerning protection of children will be of help to the Sub-
committee in its deliberations. I would, of course, be pleased to respond to any spe-
cific queries that may arise.
Sincerely,
Alfred Sommer, MD, MHS
Dean
National Institute of Allergy and Infectious Diseases
Potomac, Maryland 20854
May 9, 2005
The Honorable Daniel R. Levinson
Inspector General
U.S. Department of Health and Human Services
330 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Mr. Levinson:
I am writing you in fulfillment of my obligation as a federal employee of the Na-
tional Institutes of Health to report possible waste and fraud under Executive Order
12674 and 12731, and NIH Policy Manual, Section 1754(C)(1)(a), (b) and (c). Cur-
rently I am the Director of the Office of Policy in Clinical Research Operations
(OPCRO) in the Division of AIDS of the National Institute of Allergy and Infectious
Diseases (NIAID).
On Wednesday, May 4th, the Associated Press (AP) reported:
Government-funded researchers tested AIDS drugs on hundreds of foster children
over the past two decades, often without providing them a basic protection afforded
in federal law and required by some states.
62
The basic protection denied these foster children was the appointment of an advo-
cate “to act in the best interests of the child,” as explicitly required by 45 CFR
46.409:
§46.409 Wards.
(a) Children who are wards of the State or any other agency, institution, or entity
can be included in research approved under §46.406 or §46.407 only if such re-
search is:
(1) related to their status as wards; or
(2) conducted in schools, camps, hospitals, institutions, or similar settings in
which the majority of children involved as subjects are not wards.
(b) If the research is approved under paragraph (a) of this section, the IRB shall
require appointment of an advocate for each child who is a ward, in addition to any
other individual acting on behalf of the child as guardian or in loco parentis. One
individual may serve as advocate for more than one child. The advocate shall be an
individual who has the background and experience to act in, and agrees to act in,
the best interests of the child for the duration of the child’s participation in the re-
search and who is not associated in any way (except in the role as advocate or mem-
ber of the IRB) with the research, the investigator(s), or the guardian organization.
The AP report further states:
The research was conducted in at least seven states — Illinois, Louisiana, Mary-
land, New York, North Carolina, Colorado and Texas — and involved more than four
dozen different studies. The foster children ranged from infants to late teens, accord-
ing to interviews and government records.
These clinical research studies were funded primarily through grants awarded to
researchers by the Division of AIDS (DAIDS).
I would like to bring to your attention that according to the NIAID Clinical Terms
of Award: All clinical research supported by NIAID must comply with applicable
Parts of U.S. Code of Federal Regulations, Title 45, Part 46 “Protection of human
subjects.” (Emphasis added)
The failure of numerous DAIDS/NIAID-sponsored researchers and their institu-
tions to assure that foster children enrolled in their research were appointed indi-
vidual advocates even where a foster parent exists constitutes a violation of the
terms of their grant awards. By any definition, this is a severe violation because
it directly impacts the health and safety of foster children, among the most vulner-
able populations in our society.
Please be advised that 45 CFR 46.409 contains no exceptions to the require-
ment that foster children enrolled in research must be provided with advocates, al-
though an advocate may serve more than one child.
The claim by some researchers that “oversight boards may decline to appoint ad-
vocates if they conclude the experimental treatment affords the same or better risk-
benefit possibilities than alternate treatments already in the marketplace” is simply
false. There is no provision in either law or regulation that allows research-
ers or their oversight boards to waive the rights of children in clinical trials
to have advocates.
I ask that the your office immediately conduct an investigation to determine
which foster children were denied their rights under the law and to seek a full re-
covery of grant funds from the researchers responsible for this lapse.
Furthermore, I respectfully suggest that your review include a comprehensive fi-
nancial and protocol audit of each of the research entities and clinical trial sites in-
volved in these studies. As part of this inquiry, the medical and study records of
each foster child enrolled in their respective AIDS clinical trial should be examined
to determine whether any of these children were subjected to unnecessary risk or
injury owing to the toxicity of the drugs administered to them, and whether the re-
searchers complied with their obligations to report all adverse events.
Your office should be aware that DAIDS/NIAID currently is soliciting applications
for HIV/AIDS Clinical Trials Networks and Clinical Trial Units. Applications are
due this month and in July, 2005, respectively. Funding for both is expected to total
up to $300 million for the first year and may continue for up to seven years. (See:
http://www2.niaid.nih.gOv/newsroom/Releases/ctu2005).
It is expected that many of the investigators and their institutions responsible for
enrolling foster children in AIDS clinical trials without the appointment of advo-
cates will be competing for the upcoming award.
It is wholly inappropriate for DAIDS/NIAID to consider making awards to any of
these applicants who have violated basic human research protections until a full,
open and independent investigation has concluded and full restitution is made to
both the government and the victims of these unlawful experiments.
63
Thank you for your time and attention to this important matter. Please feel free
to contact me at my home telephone number, 301/983^370 if I can be of further
assistance.
Sincerely,
Jonathan M. Fishbein, M.D.
Director
Division of Aids
Office for Policy in Clinical Research Operations
Submission of John Mattingly, New York City Administration for
Children’s Services, New York, New York
Good afternoon Chairman Herger and Members of the Subcommittee. I am John
Mattingly, Commissioner of the New York City Administration for Children’s Serv-
ices (Children’s Services) and I submit this testimony on behalf of Children’s Serv-
ices regarding participation of children in foster care in HIV/AIDS clinical trials
during the late 1980’s and early 1990’s.
As a professional whose career has been focused in child welfare for over 30 years,
I want to begin by stating that it is imperative — both in terms of our own institu-
tional integrity and our critically important relations with the communities we
serve — that the serious questions that have been raised regarding inclusion of chil-
dren in foster care in HIV clinical trials are fully explored, and that that review
process be transparent to the public and conducted with due diligence.
That is why I have asked the Vera Institute, a New York-based not-for-profit re-
search institute which works with government to study a variety of social issues,
to conduct a comprehensive analysis. An independent Medical Oversight Committee,
consisting of nationally known experts in pediatric AIDS, medical ethics, and the
taxonomy of clinical trials, will review, respond to, and provide guidance to the Vera
Institute’s review of cases. Having said that, I want to make equally clear that I
have seen no evidence to date of any wrongdoing or malfeasance in regard to these
clinical trials, and much of what I’ve seen speaks to the good faith of those who had
decision-making authority at that time.
History of Clinical Trials in New York City
Along these lines, I would first like to bring us back to the calamity that befell
New York City and its children in the late 1980’s and early 1990’s with the arrival
of the AIDS epidemic in the lives of infants and children.
At that time, HIV/AIDS, fueled in part by the crack crisis, had reached epidemic
levels in New York City, and no effective treatment or medical regimen to manage
the disease had yet been found for children, nor did such treatment appear immi-
nent. The mortality rate for those who suffered from full-blown AIDS was 100 per-
cent. Newspapers and scientific journals, as well as doctors, social workers and ad-
ministrators in the child welfare system, hospitals and beyond, struggled with stem-
ming the ominous tide of a disease that, at that time, had no end in sight.
The impact the disease was having on many of the City’s children and families
was devastating. Media accounts from those years described the funerals of children
who had died of AIDS, of children desperately tr3dng to hide from their friends the
fact that they had been infected with the HIV virus, and of boys and girls who were
spending their early years in and out of the hospital, suffering from repeated bouts
of pneumonia and other illnesses as a result of their HIV infection. All this suffering
occurred without any medical regimen available to even begin addressing their ill-
ness.
At that same time, the scientific community was advocating strongly for making
available to children those HIV/AIDS drugs that were beginning to make a dif-
ference for adults afflicted with AIDS and the HIV virus. The journal Science, one
of the most respected scientific publications in the world, published an October 1989
article on the subject. The author described as “heartrending,” the lack of avail-
ability of AIDS drugs for children, who were characterized as “being left out in the
cold.”
Some of the doctors and nurses who treated children infected with HIV/AIDS as
well as social workers who cared for many of them have told us about the heart-
break they experienced, as they watched children suffer and die. They also told us
of their heartrending frustrations that there was so little they could offer by way
of treatment.
The cold numbers bear out what the written historical record reveals: in March
1987, 183 children under the age of 13 with full-blown AIDS had been reported to
64
the City’s Department of Health (DOH). In 1991, just four years later, DOH re-
ported that the number of children in the City with the disease had nearly quad-
rupled, to 745. By then, these reported cases comprised 26 percent of the nationwide
pediatric caseload. Even more alarming was the fact that City health officials at the
time believed that there were far more children infected with the HIV virus who
had not yet developed the AIDS disease.
The vast majority of HIV positive children contracted the virus perinatally. Of the
131,498 babies born in New York City in 1990, 1,644, or 1.25 percent, tested positive
for HIV.
Nationally, according to the Centers for Disease Control, some 14,000 children
under age 13 had been diagnosed as HIV positive or had developed AIDS between
the time of the emergence of the illness in the mid 1980’s and 1993. During the
same period in New York City, 3,634 children under 13 were diagnosed as HIV posi-
tive or as having developed AIDS.
In 1989, the NIH AIDS Program Advisory Committee recommended “cutting
through” bureaucracies that prevent children from receiving potentially beneficial
treatment through involvement in research. The NIH sponsored clinical trials in
seven states: Colorado, Illinois, Louisiana, Maryland, New York, North Carolina and
Texas. Also, in 1989, the Secretary for Health and Human Services’ Workgroup on
Pediatric HIV Infection and Disease, supported by the AmericanAcademy of Pediat-
rics, recommended that guidelines be developed governing the participation of foster
care children in HIV clinical trials.
The City of New York’s Previous Procedures
In 1988, at the urging of local hospitals, health care workers, and advocacy
groups, the New York City Human Resources Administration (HRA) and its Child
Welfare Administration (CWA), first began to develop its policy to allow children in
foster care to participate in HIV clinical trials. This decision was made in the face
of the rising number of HIV positive children in the New York City foster care sys-
tem with high rates of illness and death.
Those urging HRA to develop such a policy argued that foster children with HIV/
AIDS should not be categorically denied access to promising treatments that were
available to children not in foster care who were already being enrolled in these
trials by their parents. At the time, AZT had just been approved for use in adults
and was about to begin trials in children; it was the first medication demonstrated
to slow the progression of AIDS. The only way to receive the medication or medica-
tion regimen was to participate in a clinical trial. These medications were not avail-
able to children outside of the trials, even though in many cases adults were receiv-
ing the medications with prescriptions.
Before making the policy decision that HRA would consider the enrollment of chil-
dren in foster care in HIV clinical trials when appropriate, HRA conducted an ex-
haustive review of the ethical, medical, and legal implications of foster child partici-
pation in clinical trials. The decision to go forward was also made after meeting
with representatives from the NIH and with several of the New York City inves-
tigating physicians who were conducting clinical trials. A series of discussions with
NIH were held in order to clarify the process for its scientific approval of protocols.
Consultations were also held with representatives from the New York City Depart-
ment of Health, the New York State AIDS Institute, and the National Medical Asso-
ciation.
On January 24, 1989, HRA approved the first HIV clinical trial for participation
by children in its care. HRA made an initial decision that because certain clinical
trials offered children a therapeutic benefit they fell under the umbrella of “medical
treatment” and outside the definition of human research. The essential criterion for
permitting such participation was a determination by HRA that the trial offered
each participating foster child a significant potential treatment benefit, along with
concomitant minimal risk of injury or harm.
The early approach to assessing a clinical trial and then agreeing to enroll a child
from foster care was so cautious and the review process in place was so cumbersome
that the medical community and advocacy groups excoriated HRA for delaying crit-
ical medical care for terminally ill children, and urged HRA to speed up its clinical
trial approval process. Otherwise, these groups argued, children would miss the op-
portunity to enroll, or their disease would progress to a point where they could no
longer benefit from the new treatments.
In response, HRA developed a new procedure, which provided comparable safe-
guards for children, while addressing the need for timely response. Beginning in
1991, the NIH agreed to forward approved clinical trial protocols to HRA while local
hospital Institutional Review Boards were conducting their own reviews. HRA then
convened a panel of two to four physicians specializing in pediatric HIV/AIDS, as
65
well as program staff from the HRA/CWA Pediatric AIDS Unit (PAU) and HRA
legal staff. The physicians on the panel would conduct a scientific and medical anal-
ysis, including whether there was a significant potential medical benefit for the par-
ticipants, and a discussion of the risks associated with the trial. CWA program staff
would weigh in, offering opinions on the protocol based on the agency’s policy.
Next, the legal staff would synthesize this material, write a description and anal-
ysis of the protocol for the HRA Commissioner and state a legal opinion regarding
whether enrollment in the protocol was allowable under state law. The final deter-
mination for permitting children to enroll in the HIV clinical trial was made by the
Commissioner. For approved trials, a letter of agreement was signed between the
investigating physician at the hospital and the HRA Commissioner.
When the Commissioner of HRA agreed to permit the enrollment of children in
foster care in particular clinical trials, it was because, after a multi-level review that
included the participation of medical professionals, the Commissioner had deter-
mined that those trials provided significant potential medical treatment not avail-
able outside of the clinical trial. The determination as to whether it was appropriate
for a particular child to participate in a particular trial would follow the approval
of the trial itself for potential enrollment by children in care. That determined, the
consent from the parent would then be sought and obtained, unless the parents’
whereabouts were unknown or the child was freed for adoption, in which case the
Commissioner or his/her designee would consent.
Those HIV protocols that had been approved for foster children all had a treat-
ment arm that offered a promising drug or therapy that would otherwise be unavail-
able to foster children and were being provided to children not in foster care who
were enrolled in the clinical trials. While it was recognized that there were some
risks involved in the use of these treatments, such risks were deemed minimal com-
pared to the contemplated benefits for these children.
As the number of pediatric AIDS cases increased across the United States, the
National Institutes of Health (NIH) AIDS Program Advisory Committee (as reported
in a 1992 U.S. Surgeon General report entitled “Points to Consider: Involving HIV
Positive Foster Children Who Are Wards Of The State in HIV! AIDS Research”)
raised issues concerning foster children in clinical trials. “Committee members rec-
ommended “eutting through” bureaucracies that prevent children from receiving po-
tentially beneficial treatment through involvement in research. The Ameriean Acad-
emy of Pediatries (AAP) Committee on Drugs endorsed the inclusion of children in
state care! custody in clinical trials in certain cireumstanees. The AAP also raised
concern about the lack of participation of children in clinieal research and reported
that only a small fraction of all drugs marketed in the U.S. had clinical trials per-
formed in pediatrie patients. The AAP has eontinually supported the inelusion of
children in clinical trials as a way of protecting children not only from the harms
of life threatening diseases, but because clinical trials are a controlled setting, they
also protect children from harms which might result from ehildren taking medica-
tions whose dosages have only been tested in adult populations.”
In 1996, the New York City Administration for Children’s Services was estab-
lished. The policies and procedures from CWA were continued under Children’s
Services unless specifically changed. In 1998, Children’s Services revised its HIV
testing and assessment procedure and included in the new procedure a section on
clinical trial enrollment, modifying the existing HRA procedure.
Through this new procedure, the threshold question when a foster child’s partici-
pation in a clinical trial was being considered continued to be whether the clinical
trial offered a significant potential benefit to the child, with a concomitant minimal
risk of injury or harm. Children’s Services continued to convene its panel of experts
in pediatric HIV disease to advise the agency of the risks and benefits of proposed
studies or trials for children in foster care suffering with HIV/AIDS. This panel of
experts, together with Children’s Services professional staff, then heard a presen-
tation given by the lead physician at the hospital conducting the trial.
The Commissioner, after reviewing the recommendations made by Children’s
Services legal and medical staff, as well as the written scientific evaluation and the
protocol from the physicians on the panel, then decided whether that trial was ap-
propriate for children in foster care. Also, for a foster child to be enrolled in the
trial, the child’s mother or legally acknowledged father had to consent to the child’s
participation if her or his whereabouts were known to Children’s Services. The
child’s foster parent could not provide consent. If the child’s birth parent could not
be located after written and documented reasonable efforts, Children’s Services
would make the decision.
One key addition was included in the policy enacted in 1998: once all of the appro-
priate actions were taken leading up to an executed agreement for the trial, it then
66
required that an independent physician would review each child’s case to confirm
that the study enrollment would provide the best available treatment for that child.
In most of the clinical trials that Children’s Services has reviewed to date, the
medications had already been FDA approved for adults and the clinical trials were
intended to determine what dosage of the medication would be advantageous for
children. In other trials, the medications had been individually FDA approved and
these clinical trials were to evaluate the effects of comhination treatments and dos-
age involving those medications. In fact, Children’s Services only approved clinical
trials where risks and discomforts to children were minimized and the therapeutic
value outweighed the risks.
The vast majority of clinical trials were conducted very early on in the HIV/AIDS
epidemic and only half the clinical trials reviewed were accepted for participation.
Between 1996, when Children’s Services was established as an independent agency,
and 2001, only four trials were approved and one of these was approved for one
child only. No clinical trials have been approved since 2001.
In the late 1990’s, there was a dramatic shift in the field of pediatric AIDS, as
effective treatments were at last available outside of clinical trials, treatments
which had been developed as a result of the information learned from earlier clinical
trials. At the same time, fewer infants were born HIV positive due to medical inter-
ventions that dramatically reduced the rate of perinatal transmission. As noted in
a New York Times article dated January 30, 2005, “AIDS among infants . . . may
be on the verge of being eliminated in the United States. . . .” As a result, there
was no longer a pressing need for children to have access to clinical trials, except
in isolated instances, where HIV infected children had developed resistance to exist-
ing medications.
Recent Events
Beginning in March 2004, Children’s Services initiated an extensive review of the
agency’s PAU hard copy files on HIV children who participated in clinical trials.
This review garnered a list of 89 children who appeared to have participated in clin-
ical trials at some point between 1989 and 2001.
To have a more complete understanding of the clinical trial enrollment process,
24 cases were selected for a detailed medical record review. The sample included
11 children currently in foster care; 7 children who, at the time, had been dis-
charged from foster care within the past 2 years, either through adoption or reunifi-
cation; and 6 children who died while in foster care. All of the six children who were
deceased had died between 1992 and 1998. There was nothing in the records to sug-
gest that clinical trial medications contributed in any way to the children’s deaths.
On the contrary, it appears that the medications extended the lives of many chil-
dren. Five of the children died of AIDS-related illnesses and one died of unrelated
causes.
I decided to conduct an internal query of agency records to be sure that Children’s
Services had identified and reviewed all information pertaining to the enrollment
of foster children in clinical trials. It was determined through that review that more
children had been enrolled in clinical trials than were identified in the initial re-
view. At this time. Children’s Services believes that approximately 465 children
were enrolled in clinical trials.
Development of New Policy
We are now near finalization of a new policy governing the enrollment of children
in clinical trials. Beginning last summer, this policy was developed after a series
of meetings with focus groups and interviews with a multidisciplinary group of ex-
perts in pediatric HIV/AIDS. It will add additional protections for children in care
including clarification regarding the importance of parental consent and child as-
sent. This proposed policy would further protect children, by guarding against any
potential conflicts of interest or appearances thereof on the part of physicians who
review clinical trials and make recommendations regarding enrollment of children
in foster care.
It is important to note that this policy is being revised to provide further protec-
tions as an additional safeguard; not because any information suggests children
were inappropriately enrolled in clinical trials was uncovered. We will be glad to
share this new policy upon completion of its revision.
Vera Institute of Justice Review
I have asked the Vera Institute of Justice, to research Children’s Services’ policies
and procedures to ensure that HIV-positive children and children with AIDS who
were in our care were appropriately enrolled in clinical trials. The Vera Institute
is particularly well qualified to carry out this kind of investigation. Over more than
four decades, Vera has developed an international reputation as an independent.
67
nonprofit organization that provides the highest quality research on a wide range
of justice-related issues. The analysis organized by the Vera Institute will also ex-
amine whether:
• all necessary consents by parents and other guardians were obtained,
• the individual children’s enrollments in clinical trials were reasonable and ap-
propriate, given the scientific knowledge and medical options available at the
time,
• NIH protocols were followed, and
• HRA and Children’s Services properly monitored children after they were en-
rolled.
The Vera Institute will also seek to locate the children who participated in these
trials while in foster care to ascertain their current medical condition and solicit
their feedback regarding the medical care they received.
We have asked Vera to conduct this study in order to address ongoing questions
from the public and the press about the history of clinical trials. Vera is committed
to developing this comprehensive and transparent understanding of Children’s Serv-
ices’ policies and practices during this period. Although we believe that the policies
in place at the time reflected good practice, and while we have seen no evidence that
would cast doubt on the intentions of those in decision-making authority at the
time, we are committed to providing transparent and accurate information in our
dealings with the public.
In order for us to be effective in our mission to protect New York City’s children,
it is my firm belief that we must have a sense of mutual trust with those families
we seek to serve. I have only been the Commissioner of ACS since August of 2004
but I have worked in the field of child welfare for most of my professional life, and
I certainly understand why this is a subject that causes great concern. It involves
the well being of children, sick children, and vulnerable children who were in the
care of Children’s Services and not in the care of their own parents. We will do all
we can to ensure that Vera’s review fully answers all public concerns about the par-
ticipation of New York City foster children in HIV clinical trials, in the late 1980’s
and 1990’s.
Vera will organize a review of case records and medical records for all of the chil-
dren identified as clinical trial participants, and will prepare a public report regard-
ing its findings. Vera’s work will be reviewed by an independent Medical Oversight
Committee (Committee), consisting of nationally known experts in pediatric AIDS,
medical ethics, and taxonomy of clinical trials. These independent experts — whose
work will be funded by private foundations — will provide oversight for Children’s
Services’ current policies and comment on the Vera review. This Committee will pro-
vide additional expertise and accountability for all of the City’s actions as part of
the Vera Institute’s review. The Committee’s findings will include recommendations
for future Children’s Services policy regarding clinical trial participation, as well as
an analysis of the procedures and protocols that were used in the past. Dr. Robert
L. Johnson, an expert on HIV/AIDS, will chair the Committee. As with the Vera In-
stitute’s report, the Committee’s comments will be public.
Concurrent with the Vera Institute’s review. Children’s Services will conduct addi-
tional case record reviews to ensure that every child in foster care who participated
in clinical trials has been identified, and will continue to interview Children’s Serv-
ices staff members who played a role in developing and implementing the HIV clin-
ical trial policy over the last eighteen years.
Conclusion
Faced with an AIDS epidemic in the late 1980’s and early 1990’s, left without ef-
fective treatment for children, and at the urging of medical professionals, HRA de-
veloped its policy in an effort to allow children in foster care to have access to medi-
cation that was being made available to children not in foster care. The essential
criterion for permitting the participation of children in foster care was a determina-
tion by HRA that the trial offered each participating child a significant potential
treatment benefit, along with concomitant minimal risk of injury or harm.
Statement of Stephen A. Spector, M.D., Pediatric Aids Clinical Trials
Group, and University of California, San Diego, La Jolla, California
My name is Stephen A. Spector, M.D. I am a Professor of Pediatrics at the Uni-
versity of California, San Diego, and Principal Investigator and Chair of the Execu-
tive Committee of the Pediatric AIDS Clinical Trials Group (PACTG). Over the past
68
16 years the PACTG, funded by the National Institute of Allergy and Infectious Dis-
eases and National Institute of Child Health and Development, has been the world
leader in the development of therapies to prevent the HIV mother-to-child-trans-
mission and to treat children infected with HIV. It is the organization that is most
responsible for changing pediatric HIV/AIDS from a once invariably fatal disease to
a chronic illness. I believe my comments, in large part, reflect the opinions of all
PACTG investigators and the American Academy of Pediatrics.
I am pleased to have an opportunity to respond to the unfounded suggestions by
some that HIV-infected foster children were inappropriately enrolled in clinical
trials. In the 1980s and for much of the 1990s, HIV/AIDS was a fatal disease with
many children not surviving beyond their first few years of life. Limited treatments
were available and the only access for children to potentially life saving medications
was through clinical trials. These experimental therapies were unproven, but offered
hope for HIV-infected children and their families. Investigators of the PACTG of-
fered children the opportunity to participate in clinical trials regardless of race, eth-
nicity, creed or financial status. As pediatricians and child advocates, every effort
was made to make these potentially life saving treatments available to children who
were HIV infected and in foster care. At no time were clinical trials targeted for
foster children and foster children comprised only a small proportion children who
participated in any study. The suggestion that foster children were specifically sin-
gled out for participation in studies of new treatments is not only false, but under-
mines the heroic efforts of many dedicated health professionals who worked tire-
lessly to help save the lives of all children with HIV/AlDS. In fact, many foster chil-
dren are alive today because they able to receive “experimental” drugs that were
only available, at that time, as part of clinical trials. To have left foster children
out of these clinical trials would have deprived them of benefits provided to other
children.
All children, including those in foster care, are perhaps the most vulnerable group
of the general population with regard to possible exploitation in clinical research
protocols, and yet they are the ^oup that can often have the most significant and
prolonged benefit from such studies. Every effort must be made to retain the dignity
and well-being of children in every step of the clinical protocol process. This includes
the request for study participation, explanation of risks and benefits of a study, ob-
taining consent from parents (and in the case of foster children, a court appointed
advocate) and assent from children of appropriate age, monitoring for treatment side
effects, and presentation and publication of research findings. The success of treat-
ments for children with HIV/AIDS demonstrates the benefits that studies of new
drugs can provide not only for HIV-infected children but also for children with other
potentially fatal diseases. To deny children in foster care an opportunity to benefit
from such treatments would be medically unacceptable and morally reprehensible.
Despite the many advances that have been made in the treatment of children
with HIV/AIDS, much research remains to be done before there is a cure. HlV-in-
fected children must continue to have access to new treatments. The differences of
biological and chemical handling of drugs in children is well known, and the as-
sumption that drug processing will be similar to that in adults and will require a
simple dose reduction for children, has proven time and again to be flawed. Thus,
therapeutic and preventive interventions must be studied in children and not ex-
trapolated from studies in adults. Investigators, sponsors, research review boards,
regulators, and others engaged in pediatric research are rightly held to a higher
standard of concern because of the fragile nature of children and their rights to a
life as free as possible from pain and suffering. However, the zeal to protect children
from any harm in entering into clinical trials must be transformed into a passion
to provide children with scientific information on drugs that might vastly improve
the quality of their lives.
Although we can celebrate the great strides that have been made in treating chil-
dren infected with HIV, many improvements are still required to optimize and hope-
fully one day cure HIV/AIDS. All HIV-infected children, including those in foster
care, should continue to have an opportunity to receive treatment with these new
potentially beneficial drugs as they become available.
Statement of Patricia Sabato, Sandy Hook, Connecticut
My name is Patricia Sabato. I’m from Newtown, CT and am writing to you re-
garding the hearings on clinical drug trials in children. My son Stephen was put
on Dexedrine Spansule by Dr. Irivin Jennings of Family and Children’s Aid in Dan-
bury. CT. He was seven years old and he ended up hospitalized at Elmcrest Hos-
69
pital in Portland, CT and was kept on the same medication. In 1998 Stephen was,
once again hospitalized. He went to Four Wind’s Hospital in Katonah, NY. He was
put on Prozac and Clonadine and received at least one injection of Thorazine. From
here he went to Hallhrooke Hospital in Westport, CT and remained on these drugs.
When he returned home, the Dr. at the Danhury Hospital CCATS program changed
him to Wellhutrin. Dr. Jennings kept Stephen on this medication until 1999. De-
spite my efforts not to medicate my son because of the negative side effects and the
behaviors he was demonstrating, and knowing some of these drugs were not FDA
approved for children, I was ordered to continue him on these drugs. July 1999 he
was placed in a Residential Treatment Center called Green Chimney’s in Brewster,
NY for one year. I was assured I would be included in his full treatment plan, I
was not. Stephen remembers having his blood taken frequently and was not sure
why. He was discharged June of 2000.1 have had a hard time obtaining any record’s
of Stephen’s. There were no safeguards for the right to refuse drugs administered
to my child during our involvement with The Department Of Children And Families
of CT or his placement at Green Chimney’s in NY. I have no idea if any information
was derived from the forced drugging of FDA unapproved medications and wonder
if my son was any part of a clinical drug study.
Rockford, IL 61103
May 31, 2005
Subcommittee on Human Resources
Committee on Ways and Means
United States House of Representatives
Chairman Herger:
The testimony of Donald Young, M.D., of U.S. Department of Health and Human
Services referred to as Protections of Children Enrolled in Clinical Trials raises
questions and concerns, as does the statement of Elizabeth Monk, of the Illinois De-
partment of Children and Family Services.
Dr. Young testifies on page 3, that, “HHS continues to believe strongly that clin-
ical trials to test new treatments in children are essential and that the framework
established by the existing regulation offers adequate protection for individuals par-
ticipating in trials.” I am appalled that any children are used as subjects in any
clinical trials and that it is sanctioned and aggressively pursued by a U.S. depart-
ment! There can be no justification for this kind of conduct! The existence of “frame-
work established by the existing regulation” does not protect and does not remove
the sting of offering up children for medical experiments! The young and old of our
society, the innocent, the weak, the defenseless and vulnerable need protection, yes,
not from a regulation of appointing an advocate, but protection from being in a class
of humans upon which researchers can gain access.
Apparently, at least one of the states do not insist on appointing an advocate un-
less there is significant risk. Ms Monk of Illinois DCFS testifies that, “If DCFS ever
decided to approve a research study that has more risk with the prospect of direct
benefit, these clinic IRBs are prepared to assign an independent advocate for our
wards in compliance with federal regulations.” There can be risk in taking an aspi-
rin! A clinical trial involving any drugs could cause serious adverse effects or even
aggravate an existing condition, cause pain and suffering and even cause death.
That is a risk! Experimenting with dosage levels causes risk and even death, all of
which I understand is a concern for this Hearing.
Dr. Young, on pages 5 and 6 refers to the lack of a “standard medical treatment”
for HIV for children in foster care and that a report prepared by HHS recommended
that State and local child welfare agencies should create systems to manage the par-
ticipation of children in foster care in special medical treatment and experimental
trials.” Again, no children should be subjected to medical experiments! Further, if
there is no standard medical treatment, THEN A STANDARD SHOULD BE DE-
VELOPED using the best known treatment! Just because there is a lack of a stand-
ard that does not justify or give leave for this Government to subject children to
experimental trials, let alone children who are most vulnerable, who cannot give in-
formed consent, and whose biological parents may be under distress and duress and
cannot give informed consent.
Refer to the testimony of Deputy Secretary Roberta Harris of Wisconsin Depart-
ment of Health and Family Services of May 18, 2005, at page 2 refers to World Med-
ical Association Declaration of Helsinki’s position on the voluntary nature of partici-
pation in research. Ms Harris states that the children in their welfare system are
70
vulnerable because of conditions in the homes they come from. There is the stress
and trauma of being removed from their homes and an economic disadvantage may
cause consent under duress. Her comments and quotes indicate how difficult it is
to reach a status of informed consent for all parties involved.
How well can one be informed in order to give INFORMED consent? Some adult
clinical trials have had tragic results, some of which have been halted before com-
pleted. Even though the subjects in those studies were adults were they truly able
to get enough information? Are there protections in place even for the adult to be
adequately informed of risks?
Dr. Young’s statement refers to “Efforts in the early 1990’s to increase the enroll-
ment of foster children in clinical trials affected state policies. Today, child welfare
agencies continue to differ in their policies regarding whether or under what cir-
cumstances children in foster care may be enrolled in clinical trials.” It is disturbing
that HHS was conduction “Efforts” to get children in clinical trials. What were these
“Efforts”? And how aggressively were they pursued? Who and what department or
what group(s) were behind the efforts? I would urge this Committee to determine
what was done to get the states to turn over their wards to the researchers. It ap-
pears, and to their credit, some states resisted.
The Associated Press articles refer to some children having serious adverse effects
from these medical experiments and even death may have resulted from experi-
menting with dosage levels. I trust this committee will investigate these matters
fully and demand accountability.
I emphasize again that no children should become subjects of medical experiments
or clinical trials. Just because a procedure was put in place to give each child an
independent advocate to monitor a child subjected to clinical trials does not justify
or make more acceptable giving access to the most vulnerable of our society to med-
ical researchers.
I refer to page 2 of Ms Monk’s (of Illinois) statement. “If DCFS ever decided to
approve a research study that has more risk without the prospect of direct benefit,
these clinic IRBs are prepared to assign an independent advocate for our wards in
compliance with federal regulations.” What? It appears that NO independent advo-
cate has been assigned and further it appears someone preordained the experiments
to be without risk!
Also, note Ms Monk says “one drug protects them from the flu.” Isn’t there a
standard medical treatment in place for the flu? If there is a standard medical treat-
ment in place for flu, how and why would Illinois give access to their wards for re-
search on flu vaccines?
I would hope that all of the Illinois cases be studied carefully. It might not be
as rosy of a picture as she paints. How many died? Were the deaths attributed to
the clinical trials? Ms Monk says 20 kids presently are on 5 research studies. That’s
twenty children too many. What are these studies for? Children as well as foster
children should not be subjected to medical experiments. The foster children in most
cases lack a loving, caring and attentive parent to protect them and cannot really
give informed consent.
There was horrific disregard for humanity that took place in World War II Ger-
many, some of which started out being directed toward the weak and vulnerable,
in orphanages and hospitals, but then was directed to millions who lost their lives
in the concentration camps. A society does not just lose their regard for human life
overnight. It is a step at a time downward and soon that society slips further and
faster downward. Many vowed, “Never Again.” We in the U.S. cannot and should
not be allowing access to our children for medical research. There is no argument
that justifies it! Perhaps we need to review the transcripts of the Nuremberg trials.
There were many, including doctors who were held accountable.
An immediate halt should be called to medical experiments on children. Further,
any unused grant money should be returned to the U.S. Treasury and any grants
used for clinical studies on children who did not get an independent advocate should
be repaid. That money won’t compensate for loss society experiences from such con-
duct, but our tax money should not be used in this manner. It’s a disgrace! If the
weak and vulnerable continue to be treated in this manner. Lord help us, it becomes
a slippery slope.
Respectfully submitted.
Sharon Schuldt
71
William Glasser, Inc.
Chatsworth, California 91311
May 20, 2005
Congressman Wally Herger
Rayburn House Office Building
Washington, D.C. 20515
I am very interested in the Congressional Hearing focused on protecting children
from being involved in experimental psychiatric drugs or drugs of any kind. Most
of the children enrolled are foster children or children who aren’t really looked after
by any protective agency. I believe the government should become the protective
agency.
I am a Board Certified Psychiatrist who has been working in mental health for
over forty years. I’ve worked not only with children and adults, but also extensively
in the schools. In the schools that are following my ideas, no children are given any
kind of psychiatric drugs at the instigation of the schools. We can’t stop parents
from giving their children these drugs, but we can certainly advise parents that
these drugs are really not necessary. These Glasser Quality Schools are highly suc-
cessful and are perhaps the most successful schools in the country where students
are not taking any psychiatric drugs.
Your legislation can certainly close a big gap to the practice of using children who
have no way of protecting themselves and no parents who are really that interested
in them. That should not be allowed. There should be some sort of protection for
the children and that protective operation should swing into operation if any chil-
dren are asked to participate in any kind of medical experimentation at all.
As a Board Member of an organization called Ablechild, I am working with Gloria
Wright and other members to reduce the drugging of all children and the practice
of advising parents to put their children on drugs. No one knows what the long-term
effects are from these drugs. The short-term effects, in many cases, are somewhat
disastrous and include violent activity and suicide.
I am the President of The William Glasser Institute. We teach and train people
to deal with mental health all over the world with adults and children. I am very
well known and have been spending most of the latter part of my professional life
warning people about the dangers of psychiatric drugs. There is no evidence that
the drugs are in any way helpful, but there is a great deal of evidence that they
may be harmful. If the purpose of our government is to protect people against un-
warranted intrusions into their privacy from the people who are making money off
of these intrusions and paying little or no attention to the children, then this is a
wrong you should certainly right.
If you would like to learn more about my work, my website address is
www.wglasser.com. You will see that there is a lot of information on the website
that supports what I am saying here.
I also appreciate being on the Ablechild Board of Directors and I am doing every-
thing I can to help them.
Cordially,
o
William Glasser, M.D.
Board Certified Psychiatrist
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